{"_meta":{"source":"FDA Enforcement Report (iRES) and FDA/manufacturer notices","built":"2026-10-28","lots":102},"lots":{"5ST2SEDWME":[{"date":"2025-04-24","product":"AREXVY, VL RESPIRATORY SYNCYTIAL VIRUS VACCINE 0.5ML (10/BX)","firm":"Mckesson Medical-Surgical Inc. Corporate Office","distributor":true,"cls":"Class II","reason":"McKesson Medical Surgical is recalling biologic products (Comirnaty, Prevnar 20, Vaxneuvance, Tenivac, Arexy, Infanrix, and ACTHIB) due to severe thunderstorms that caused transit delays resulting in temperature excursions of these cold chain products.","area":"13 Consignees located in FL, KY, MI, MS, NC, TN, and WV.","ref":"FDA Enforcement Report, recall B-0404-2025","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"JB27A":[{"date":"2025-04-24","product":"AREXVY, VL RESPIRATORY SYNCYTIAL VIRUS VACCINE 0.5ML (10/BX)","firm":"Mckesson Medical-Surgical Inc. Corporate Office","distributor":true,"cls":"Class II","reason":"McKesson Medical Surgical is recalling biologic products (Comirnaty, Prevnar 20, Vaxneuvance, Tenivac, Arexy, Infanrix, and ACTHIB) due to severe thunderstorms that caused transit delays resulting in temperature excursions of these cold chain products.","area":"13 Consignees located in FL, KY, MI, MS, NC, TN, and WV.","ref":"FDA Enforcement Report, recall B-0404-2025","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"LX4483":[{"date":"2025-04-24","product":"PREVNAR 20, PFS 0.5ML UD (10/CT)","firm":"Mckesson Medical-Surgical Inc. Corporate Office","distributor":true,"cls":"Class II","reason":"McKesson Medical Surgical is recalling biologic products (Comirnaty, Prevnar 20, Vaxneuvance, Tenivac, Arexy, Infanrix, and ACTHIB) due to severe thunderstorms that caused transit delays resulting in temperature excursions of these cold chain products.","area":"13 Consignees located in FL, KY, MI, MS, NC, TN, and WV.","ref":"FDA Enforcement Report, recall B-0401-2025","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"LK6655":[{"date":"2025-04-24","product":"PREVNAR 20, PFS 0.5ML UD (10/CT)","firm":"Mckesson Medical-Surgical Inc. Corporate Office","distributor":true,"cls":"Class II","reason":"McKesson Medical Surgical is recalling biologic products (Comirnaty, Prevnar 20, Vaxneuvance, Tenivac, Arexy, Infanrix, and ACTHIB) due to severe thunderstorms that caused transit delays resulting in temperature excursions of these cold chain products.","area":"13 Consignees located in FL, KY, MI, MS, NC, TN, and WV.","ref":"FDA Enforcement Report, recall B-0401-2025","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"Y010032":[{"date":"2025-04-24","product":"VAXNEUVANCE, SYR 0.5ML (10/BX)","firm":"Mckesson Medical-Surgical Inc. Corporate Office","distributor":true,"cls":"Class II","reason":"McKesson Medical Surgical is recalling biologic products (Comirnaty, Prevnar 20, Vaxneuvance, Tenivac, Arexy, Infanrix, and ACTHIB) due to severe thunderstorms that caused transit delays resulting in temperature excursions of these cold chain products.","area":"13 Consignees located in FL, KY, MI, MS, NC, TN, and WV.","ref":"FDA Enforcement Report, recall B-0402-2025","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"5KR3R":[{"date":"2025-04-24","product":"INFANRIX, SYR 25-58-10MG/0.5ML0.5ML (10/PK)","firm":"Mckesson Medical-Surgical Inc. Corporate Office","distributor":true,"cls":"Class II","reason":"McKesson Medical Surgical is recalling biologic products (Comirnaty, Prevnar 20, Vaxneuvance, Tenivac, Arexy, Infanrix, and ACTHIB) due to severe thunderstorms that caused transit delays resulting in temperature excursions of these cold chain products.","area":"13 Consignees located in FL, KY, MI, MS, NC, TN, and WV.","ref":"FDA Enforcement Report, recall B-0405-2025","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"UK208AA":[{"date":"2025-04-24","product":"ACTHIB, SDV 10MCG/0.5ML 0.05ML W/DILUENT (5/BX)","firm":"Mckesson Medical-Surgical Inc. Corporate Office","distributor":true,"cls":"Class II","reason":"McKesson Medical Surgical is recalling biologic products (Comirnaty, Prevnar 20, Vaxneuvance, Tenivac, Arexy, Infanrix, and ACTHIB) due to severe thunderstorms that caused transit delays resulting in temperature excursions of these cold chain products.","area":"13 Consignees located in FL, KY, MI, MS, NC, TN, and WV.","ref":"FDA Enforcement Report, recall B-0406-2025","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"MD3414":[{"date":"2025-04-24","product":"COMIRNATY 2024, COVID19 MRNA 12+ NEVER FROZEN (10DOSES/BX)","firm":"Mckesson Medical-Surgical Inc. Corporate Office","distributor":true,"cls":"Class II","reason":"McKesson Medical Surgical is recalling biologic products (Comirnaty, Prevnar 20, Vaxneuvance, Tenivac, Arexy, Infanrix, and ACTHIB) due to severe thunderstorms that caused transit delays resulting in temperature excursions of these cold chain products.","area":"13 Consignees located in FL, KY, MI, MS, NC, TN, and WV.","ref":"FDA Enforcement Report, recall B-0400-2025","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"U8492AA":[{"date":"2025-04-24","product":"TENIVAC, SYR 0.5ML (10/PK)","firm":"Mckesson Medical-Surgical Inc. Corporate Office","distributor":true,"cls":"Class II","reason":"McKesson Medical Surgical is recalling biologic products (Comirnaty, Prevnar 20, Vaxneuvance, Tenivac, Arexy, Infanrix, and ACTHIB) due to severe thunderstorms that caused transit delays resulting in temperature excursions of these cold chain products.","area":"13 Consignees located in FL, KY, MI, MS, NC, TN, and WV.","ref":"FDA Enforcement Report, recall B-0403-2025","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"HN0477":[{"date":"2024-06-03","product":"COVID-19 Vaccine, mRNA","firm":"Pfizer Manufacturing Belgium NV","distributor":false,"cls":"Class III","reason":"Pfizer confirmed that four lots of Comirnaty (Covid-19 Vaccine, mRNA), 30 mcg (2023-2024 formula) were shipped and exceeded the required 2 oC - 8 oC refrigerated box qualification for 16 deliveries of these lots potentially impacting the product.","area":"Of the 16 deliveries identified, 8 deliveries were to Alaskan cities (Craig, Talkeetna, Cordova, Homer, Barrow, Fort Yukon, and Kotzebue) and 8 deliveries to U.S. Pacific Island territories were impacted (N. Mariana Islands, Guam, Micronesia, and Palau).","ref":"FDA Enforcement Report, recall B-0077-2025","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"HN0478":[{"date":"2024-06-03","product":"COVID-19 Vaccine, mRNA","firm":"Pfizer Manufacturing Belgium NV","distributor":false,"cls":"Class III","reason":"Pfizer confirmed that four lots of Comirnaty (Covid-19 Vaccine, mRNA), 30 mcg (2023-2024 formula) were shipped and exceeded the required 2 oC - 8 oC refrigerated box qualification for 16 deliveries of these lots potentially impacting the product.","area":"Of the 16 deliveries identified, 8 deliveries were to Alaskan cities (Craig, Talkeetna, Cordova, Homer, Barrow, Fort Yukon, and Kotzebue) and 8 deliveries to U.S. Pacific Island territories were impacted (N. Mariana Islands, Guam, Micronesia, and Palau).","ref":"FDA Enforcement Report, recall B-0077-2025","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"LC4370":[{"date":"2024-06-03","product":"COVID-19 Vaccine, mRNA","firm":"Pfizer Manufacturing Belgium NV","distributor":false,"cls":"Class III","reason":"Pfizer confirmed that four lots of Comirnaty (Covid-19 Vaccine, mRNA), 30 mcg (2023-2024 formula) were shipped and exceeded the required 2 oC - 8 oC refrigerated box qualification for 16 deliveries of these lots potentially impacting the product.","area":"Of the 16 deliveries identified, 8 deliveries were to Alaskan cities (Craig, Talkeetna, Cordova, Homer, Barrow, Fort Yukon, and Kotzebue) and 8 deliveries to U.S. Pacific Island territories were impacted (N. Mariana Islands, Guam, Micronesia, and Palau).","ref":"FDA Enforcement Report, recall B-0077-2025","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"HM7006":[{"date":"2024-06-03","product":"COVID-19 Vaccine, mRNA","firm":"Pfizer Manufacturing Belgium NV","distributor":false,"cls":"Class III","reason":"Pfizer confirmed that four lots of Comirnaty (Covid-19 Vaccine, mRNA), 30 mcg (2023-2024 formula) were shipped and exceeded the required 2 oC - 8 oC refrigerated box qualification for 16 deliveries of these lots potentially impacting the product.","area":"Of the 16 deliveries identified, 8 deliveries were to Alaskan cities (Craig, Talkeetna, Cordova, Homer, Barrow, Fort Yukon, and Kotzebue) and 8 deliveries to U.S. Pacific Island territories were impacted (N. Mariana Islands, Guam, Micronesia, and Palau).","ref":"FDA Enforcement Report, recall B-0077-2025","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"MG5EJ":[{"date":"2024-02-08","product":"Shingrix Shingles Vaccine Zoster Vaccine Recombinant, Adjuvanted 50 mcg / 0.5 mL Injection…","firm":"Mckesson Medical-Surgical Inc. Corporate Office","distributor":true,"cls":"Class III","reason":"McKesson Medical Surgical (MMS) Phoenix, AZ Distribution Center experienced a critical temperature excursion in the Walk-In refrigerator due\nto mechanical failures, causing temperatures to fall below the validated range for up to 60 minutes. This incident led to stored medical products being exposed to temperatures as low as 25oF, averaging 28oF over the hour-long period.  MMS has initiated a voluntary recall for products negatively impacted by this excursion.","area":"US: TX, AZ, CA","ref":"FDA Enforcement Report, recall B-0244-2024","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"W1A101M":[{"date":"2024-02-08","product":"IPOL Polio Vaccine","firm":"Mckesson Medical-Surgical Inc. Corporate Office","distributor":true,"cls":"Class III","reason":"McKesson Medical Surgical (MMS) Phoenix, AZ Distribution Center experienced a critical temperature excursion in the Walk-In refrigerator due\nto mechanical failures, causing temperatures to fall below the validated range for up to 60 minutes. This incident led to stored medical products being exposed to temperatures as low as 25oF, averaging 28oF over the hour-long period.  MMS has initiated a voluntary recall for products negatively impacted by this excursion.","area":"US: TX, AZ, CA","ref":"FDA Enforcement Report, recall B-0237-2024","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"A146A1":[{"date":"2024-02-08","product":"TDVAX Td Vaccine Tetanus and Diphtheria Toxoids Adsorbed Injection Single-Dose Vial 0.5 mL","firm":"Mckesson Medical-Surgical Inc. Corporate Office","distributor":true,"cls":"Class III","reason":"McKesson Medical Surgical (MMS) Phoenix, AZ Distribution Center experienced a critical temperature excursion in the Walk-In refrigerator due\nto mechanical failures, causing temperatures to fall below the validated range for up to 60 minutes. This incident led to stored medical products being exposed to temperatures as low as 25oF, averaging 28oF over the hour-long period.  MMS has initiated a voluntary recall for products negatively impacted by this excursion.","area":"US: TX, AZ, CA","ref":"FDA Enforcement Report, recall B-0243-2024","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"H7RF2":[{"date":"2024-02-08","product":"Twinrix Hepatitis A and Hepatitis B Vaccine","firm":"Mckesson Medical-Surgical Inc. Corporate Office","distributor":true,"cls":"Class III","reason":"McKesson Medical Surgical (MMS) Phoenix, AZ Distribution Center experienced a critical temperature excursion in the Walk-In refrigerator due\nto mechanical failures, causing temperatures to fall below the validated range for up to 60 minutes. This incident led to stored medical products being exposed to temperatures as low as 25oF, averaging 28oF over the hour-long period.  MMS has initiated a voluntary recall for products negatively impacted by this excursion.","area":"US: TX, AZ, CA","ref":"FDA Enforcement Report, recall B-0239-2024","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"U7852AB":[{"date":"2024-02-08","product":"MenQuadfi Meningitis Vaccine Meningococcal (Groups A, C, Y, and W-135) Conjugate Vaccine, …","firm":"Mckesson Medical-Surgical Inc. Corporate Office","distributor":true,"cls":"Class III","reason":"McKesson Medical Surgical (MMS) Phoenix, AZ Distribution Center experienced a critical temperature excursion in the Walk-In refrigerator due\nto mechanical failures, causing temperatures to fall below the validated range for up to 60 minutes. This incident led to stored medical products being exposed to temperatures as low as 25oF, averaging 28oF over the hour-long period.  MMS has initiated a voluntary recall for products negatively impacted by this excursion.","area":"US: TX, AZ, CA","ref":"FDA Enforcement Report, recall B-0247-2024","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"P5SR5":[{"date":"2024-02-08","product":"Boostrix Tdap Booster Vaccine Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pert…","firm":"Mckesson Medical-Surgical Inc. Corporate Office","distributor":true,"cls":"Class III","reason":"McKesson Medical Surgical (MMS) Phoenix, AZ Distribution Center experienced a critical temperature excursion in the Walk-In refrigerator due\nto mechanical failures, causing temperatures to fall below the validated range for up to 60 minutes. This incident led to stored medical products being exposed to temperatures as low as 25oF, averaging 28oF over the hour-long period.  MMS has initiated a voluntary recall for products negatively impacted by this excursion.","area":"US: TX, AZ, CA","ref":"FDA Enforcement Report, recall B-0241-2024","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"4T39P":[{"date":"2024-02-08","product":"ENGERIX-B Hepatitis B Vaccine 20 mcg / mL Injection Prefilled","firm":"Mckesson Medical-Surgical Inc. Corporate Office","distributor":true,"cls":"Class III","reason":"McKesson Medical Surgical (MMS) Phoenix, AZ Distribution Center experienced a critical temperature excursion in the Walk-In refrigerator due\nto mechanical failures, causing temperatures to fall below the validated range for up to 60 minutes. This incident led to stored medical products being exposed to temperatures as low as 25oF, averaging 28oF over the hour-long period.  MMS has initiated a voluntary recall for products negatively impacted by this excursion.","area":"US: TX, AZ, CA","ref":"FDA Enforcement Report, recall B-0240-2024","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"2CA61C1":[{"date":"2024-02-08","product":"Adacel Tdap Vaccine","firm":"Mckesson Medical-Surgical Inc. Corporate Office","distributor":true,"cls":"Class III","reason":"McKesson Medical Surgical (MMS) Phoenix, AZ Distribution Center experienced a critical temperature excursion in the Walk-In refrigerator due\nto mechanical failures, causing temperatures to fall below the validated range for up to 60 minutes. This incident led to stored medical products being exposed to temperatures as low as 25oF, averaging 28oF over the hour-long period.  MMS has initiated a voluntary recall for products negatively impacted by this excursion.","area":"US: TX, AZ, CA","ref":"FDA Enforcement Report, recall B-0238-2024","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"TJ2944":[{"date":"2024-02-08","product":"FluMist Quadrivalent 2023 - 2024 Flu Vaccine 10E6.5 - 7.5 FFU Intranasal Sprayer 0.2 mL","firm":"Mckesson Medical-Surgical Inc. Corporate Office","distributor":true,"cls":"Class III","reason":"McKesson Medical Surgical (MMS) Phoenix, AZ Distribution Center experienced a critical temperature excursion in the Walk-In refrigerator due\nto mechanical failures, causing temperatures to fall below the validated range for up to 60 minutes. This incident led to stored medical products being exposed to temperatures as low as 25oF, averaging 28oF over the hour-long period.  MMS has initiated a voluntary recall for products negatively impacted by this excursion.","area":"US: TX, AZ, CA","ref":"FDA Enforcement Report, recall B-0248-2024","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"W027275":[{"date":"2023-09-20","product":"Pneumococcal 15-valent Conjugate Vaccine","firm":"Merck Sharp & Dohme LLC","distributor":false,"cls":"Class II","reason":"Merck Sharp & Dohme LLC became aware of Vaxneuvance breaking at the syringe flange and/or hub resulting in injury (e.g., skin laceration) during administration. Additionally, breakages were identified by healthcare professionals before administration, while securing the needle to the syringe, during vaccine administration or during post-administration (e.g., when activating a needle safety mechanism).\n\nMerck is expanding the scope of the existing recall to include all remaining lots manufactured prior to Corrective and Preventative Action (CAPA) implementation. The recall of the remaining pre-CAPA lots will be made to the wholesale level including CDC.","area":"AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KY, KS, LA, MA, ME, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY","ref":"FDA Enforcement Report, recall B-0023-2024","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"W036242":[{"date":"2023-09-20","product":"Pneumococcal 15-valent Conjugate Vaccine","firm":"Merck Sharp & Dohme LLC","distributor":false,"cls":"Class II","reason":"Merck Sharp & Dohme LLC became aware of Vaxneuvance breaking at the syringe flange and/or hub resulting in injury (e.g., skin laceration) during administration. Additionally, breakages were identified by healthcare professionals before administration, while securing the needle to the syringe, during vaccine administration or during post-administration (e.g., when activating a needle safety mechanism).\n\nMerck is expanding the scope of the existing recall to include all remaining lots manufactured prior to Corrective and Preventative Action (CAPA) implementation. The recall of the remaining pre-CAPA lots will be made to the wholesale level including CDC.","area":"AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KY, KS, LA, MA, ME, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY","ref":"FDA Enforcement Report, recall B-0023-2024","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"W037992":[{"date":"2023-09-20","product":"Pneumococcal 15-valent Conjugate Vaccine","firm":"Merck Sharp & Dohme LLC","distributor":false,"cls":"Class II","reason":"Merck Sharp & Dohme LLC became aware of Vaxneuvance breaking at the syringe flange and/or hub resulting in injury (e.g., skin laceration) during administration. Additionally, breakages were identified by healthcare professionals before administration, while securing the needle to the syringe, during vaccine administration or during post-administration (e.g., when activating a needle safety mechanism).\n\nMerck is expanding the scope of the existing recall to include all remaining lots manufactured prior to Corrective and Preventative Action (CAPA) implementation. The recall of the remaining pre-CAPA lots will be made to the wholesale level including CDC.","area":"AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KY, KS, LA, MA, ME, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY","ref":"FDA Enforcement Report, recall B-0023-2024","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"W039033":[{"date":"2023-09-20","product":"Pneumococcal 15-valent Conjugate Vaccine","firm":"Merck Sharp & Dohme LLC","distributor":false,"cls":"Class II","reason":"Merck Sharp & Dohme LLC became aware of Vaxneuvance breaking at the syringe flange and/or hub resulting in injury (e.g., skin laceration) during administration. Additionally, breakages were identified by healthcare professionals before administration, while securing the needle to the syringe, during vaccine administration or during post-administration (e.g., when activating a needle safety mechanism).\n\nMerck is expanding the scope of the existing recall to include all remaining lots manufactured prior to Corrective and Preventative Action (CAPA) implementation. The recall of the remaining pre-CAPA lots will be made to the wholesale level including CDC.","area":"AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KY, KS, LA, MA, ME, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY","ref":"FDA Enforcement Report, recall B-0023-2024","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"X004289":[{"date":"2023-09-20","product":"Pneumococcal 15-valent Conjugate Vaccine","firm":"Merck Sharp & Dohme LLC","distributor":false,"cls":"Class II","reason":"Merck Sharp & Dohme LLC became aware of Vaxneuvance breaking at the syringe flange and/or hub resulting in injury (e.g., skin laceration) during administration. Additionally, breakages were identified by healthcare professionals before administration, while securing the needle to the syringe, during vaccine administration or during post-administration (e.g., when activating a needle safety mechanism).\n\nMerck is expanding the scope of the existing recall to include all remaining lots manufactured prior to Corrective and Preventative Action (CAPA) implementation. The recall of the remaining pre-CAPA lots will be made to the wholesale level including CDC.","area":"AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KY, KS, LA, MA, ME, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY","ref":"FDA Enforcement Report, recall B-0023-2024","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"X005583":[{"date":"2023-09-20","product":"Pneumococcal 15-valent Conjugate Vaccine","firm":"Merck Sharp & Dohme LLC","distributor":false,"cls":"Class II","reason":"Merck Sharp & Dohme LLC became aware of Vaxneuvance breaking at the syringe flange and/or hub resulting in injury (e.g., skin laceration) during administration. Additionally, breakages were identified by healthcare professionals before administration, while securing the needle to the syringe, during vaccine administration or during post-administration (e.g., when activating a needle safety mechanism).\n\nMerck is expanding the scope of the existing recall to include all remaining lots manufactured prior to Corrective and Preventative Action (CAPA) implementation. The recall of the remaining pre-CAPA lots will be made to the wholesale level including CDC.","area":"AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KY, KS, LA, MA, ME, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY","ref":"FDA Enforcement Report, recall B-0023-2024","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"X011328":[{"date":"2023-09-20","product":"Pneumococcal 15-valent Conjugate Vaccine","firm":"Merck Sharp & Dohme LLC","distributor":false,"cls":"Class II","reason":"Merck Sharp & Dohme LLC became aware of Vaxneuvance breaking at the syringe flange and/or hub resulting in injury (e.g., skin laceration) during administration. Additionally, breakages were identified by healthcare professionals before administration, while securing the needle to the syringe, during vaccine administration or during post-administration (e.g., when activating a needle safety mechanism).\n\nMerck is expanding the scope of the existing recall to include all remaining lots manufactured prior to Corrective and Preventative Action (CAPA) implementation. The recall of the remaining pre-CAPA lots will be made to the wholesale level including CDC.","area":"AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KY, KS, LA, MA, ME, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY","ref":"FDA Enforcement Report, recall B-0023-2024","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"X011332":[{"date":"2023-09-20","product":"Pneumococcal 15-valent Conjugate Vaccine","firm":"Merck Sharp & Dohme LLC","distributor":false,"cls":"Class II","reason":"Merck Sharp & Dohme LLC became aware of Vaxneuvance breaking at the syringe flange and/or hub resulting in injury (e.g., skin laceration) during administration. Additionally, breakages were identified by healthcare professionals before administration, while securing the needle to the syringe, during vaccine administration or during post-administration (e.g., when activating a needle safety mechanism).\n\nMerck is expanding the scope of the existing recall to include all remaining lots manufactured prior to Corrective and Preventative Action (CAPA) implementation. The recall of the remaining pre-CAPA lots will be made to the wholesale level including CDC.","area":"AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KY, KS, LA, MA, ME, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY","ref":"FDA Enforcement Report, recall B-0023-2024","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"X011735":[{"date":"2023-09-20","product":"Pneumococcal 15-valent Conjugate Vaccine","firm":"Merck Sharp & Dohme LLC","distributor":false,"cls":"Class II","reason":"Merck Sharp & Dohme LLC became aware of Vaxneuvance breaking at the syringe flange and/or hub resulting in injury (e.g., skin laceration) during administration. Additionally, breakages were identified by healthcare professionals before administration, while securing the needle to the syringe, during vaccine administration or during post-administration (e.g., when activating a needle safety mechanism).\n\nMerck is expanding the scope of the existing recall to include all remaining lots manufactured prior to Corrective and Preventative Action (CAPA) implementation. The recall of the remaining pre-CAPA lots will be made to the wholesale level including CDC.","area":"AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KY, KS, LA, MA, ME, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY","ref":"FDA Enforcement Report, recall B-0023-2024","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"X012044":[{"date":"2023-09-20","product":"Pneumococcal 15-valent Conjugate Vaccine","firm":"Merck Sharp & Dohme LLC","distributor":false,"cls":"Class II","reason":"Merck Sharp & Dohme LLC became aware of Vaxneuvance breaking at the syringe flange and/or hub resulting in injury (e.g., skin laceration) during administration. Additionally, breakages were identified by healthcare professionals before administration, while securing the needle to the syringe, during vaccine administration or during post-administration (e.g., when activating a needle safety mechanism).\n\nMerck is expanding the scope of the existing recall to include all remaining lots manufactured prior to Corrective and Preventative Action (CAPA) implementation. The recall of the remaining pre-CAPA lots will be made to the wholesale level including CDC.","area":"AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KY, KS, LA, MA, ME, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY","ref":"FDA Enforcement Report, recall B-0023-2024","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"W021510":[{"date":"2023-07-19","product":"Pneumococcal 15-valent Conjugate Vaccine","firm":"Merck Sharp & Dohme LLC","distributor":false,"cls":"Class II","reason":"Merck Sharp & Dohme LLC became aware of Vaxneuvance (lots W021510, W027250, W021512, W021637 and W028846) breaking at the syringe flange and/or hub resulting in injury (e.g., skin laceration) during administration.  Additionally, breakages were identified by healthcare professionals before administration, while securing the needle to the syringe, during vaccine administration or during post-administration (e.g., when activating a needle safety mechanism).","area":"AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY","ref":"FDA Enforcement Report, recall B-0573-2023","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"W027250":[{"date":"2023-07-19","product":"Pneumococcal 15-valent Conjugate Vaccine","firm":"Merck Sharp & Dohme LLC","distributor":false,"cls":"Class II","reason":"Merck Sharp & Dohme LLC became aware of Vaxneuvance (lots W021510, W027250, W021512, W021637 and W028846) breaking at the syringe flange and/or hub resulting in injury (e.g., skin laceration) during administration.  Additionally, breakages were identified by healthcare professionals before administration, while securing the needle to the syringe, during vaccine administration or during post-administration (e.g., when activating a needle safety mechanism).","area":"AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY","ref":"FDA Enforcement Report, recall B-0573-2023","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"W021512":[{"date":"2023-07-19","product":"Pneumococcal 15-valent Conjugate Vaccine","firm":"Merck Sharp & Dohme LLC","distributor":false,"cls":"Class II","reason":"Merck Sharp & Dohme LLC became aware of Vaxneuvance (lots W021510, W027250, W021512, W021637 and W028846) breaking at the syringe flange and/or hub resulting in injury (e.g., skin laceration) during administration.  Additionally, breakages were identified by healthcare professionals before administration, while securing the needle to the syringe, during vaccine administration or during post-administration (e.g., when activating a needle safety mechanism).","area":"AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY","ref":"FDA Enforcement Report, recall B-0573-2023","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"W021637":[{"date":"2023-07-19","product":"Pneumococcal 15-valent Conjugate Vaccine","firm":"Merck Sharp & Dohme LLC","distributor":false,"cls":"Class II","reason":"Merck Sharp & Dohme LLC became aware of Vaxneuvance (lots W021510, W027250, W021512, W021637 and W028846) breaking at the syringe flange and/or hub resulting in injury (e.g., skin laceration) during administration.  Additionally, breakages were identified by healthcare professionals before administration, while securing the needle to the syringe, during vaccine administration or during post-administration (e.g., when activating a needle safety mechanism).","area":"AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY","ref":"FDA Enforcement Report, recall B-0573-2023","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"W028846":[{"date":"2023-07-19","product":"Pneumococcal 15-valent Conjugate Vaccine","firm":"Merck Sharp & Dohme LLC","distributor":false,"cls":"Class II","reason":"Merck Sharp & Dohme LLC became aware of Vaxneuvance (lots W021510, W027250, W021512, W021637 and W028846) breaking at the syringe flange and/or hub resulting in injury (e.g., skin laceration) during administration.  Additionally, breakages were identified by healthcare professionals before administration, while securing the needle to the syringe, during vaccine administration or during post-administration (e.g., when activating a needle safety mechanism).","area":"AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY","ref":"FDA Enforcement Report, recall B-0573-2023","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"937783":[{"date":"2022-09-26","product":"HEPLISAV-B, PFS Hepatitis B Vaccine (Recombinant), Adjuvanted","firm":"Mckesson Medical-Surgical Inc. Corporate Office","distributor":true,"cls":"Class III","reason":"McKesson Medical is recalling HEPLISAV-B because it has experienced temperature excursions and was stored at temperatures lower than those specified on the labeling prior to distribution.","area":"CA","ref":"FDA Enforcement Report, recall B-0019-2023","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"CP23D":[{"date":"2021-10-22","product":"Hepatitis B Vaccine (Recombinant)","firm":"GlaxoSmithKline Biologicals SA","distributor":false,"cls":"Class III","reason":"Following a customer complaint received by GSK on August 4, 2021, five syringes from two different cartons (three syringes out of ten in the first carton and two syringes out of ten in the second carton) from Engerix-B Pediatric single dose syringe vaccine lot CP23D had missing labels.  The complaint was substantiated by GSK following the return of the syringes missing labels. GSK has decided to voluntarily recall Engerix-B lot CP23D from the market as a precautionary measure to prevent any potential risk of maladministration.","area":"Domestic:  AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NM, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY\n\nInternational: AP, EU, GU, JP, and VI","ref":"FDA Enforcement Report, recall B-0049-2024","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"UJ575AAA":[{"date":"2021-08-09","product":"Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) ActHIB, Rx only, 5 single dose …","firm":"Medline Industries Inc","distributor":true,"cls":"Class III","reason":"Vaccines, in transit greater than allotted timeframe and potentially exceeding the required shipping temperature range, were distributed.","area":"IA, IL, IN, KS, MI, NE, WI","ref":"FDA Enforcement Report, recall B-0120-2022","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"C5788BA":[{"date":"2021-08-09","product":"Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed, 10 sin…","firm":"Medline Industries Inc","distributor":true,"cls":"Class III","reason":"Vaccines, in transit greater than allotted timeframe and potentially exceeding the required shipping temperature range, were distributed.","area":"IA, IL, IN, KS, MI, NE, WI","ref":"FDA Enforcement Report, recall B-0123-2022","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"UJ528AAA":[{"date":"2021-08-09","product":"Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus an…","firm":"Medline Industries Inc","distributor":true,"cls":"Class III","reason":"Vaccines, in transit greater than allotted timeframe and potentially exceeding the required shipping temperature range, were distributed.","area":"IA, IL, IN, KS, MI, NE, WI","ref":"FDA Enforcement Report, recall B-0122-2022","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"9LH3Y":[{"date":"2021-02-10","product":"Zoster Vaccine Live","firm":"GlaxoSmithKline Biologicals SA","distributor":false,"cls":"Class II","reason":"Vaccine, placed in glass vials found to have morphology defects, was distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-0264-2022","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"UJ541AA":[{"date":"2020-11-06","product":"Influenza Vaccine, Fluzone, High Dose, Quadrivalent, 0.7 ml, single dose, pre-filled syrin…","firm":"Medline Industries Inc","distributor":true,"cls":"Class II","reason":"A single lot of Influenza Vaccine, Fluzone, High Dose, Quadrivalent, 0.7 ml, single dose, pre-filled syringe, was shipped outside of the specified storage temperature range.","area":"US: Florida","ref":"FDA Enforcement Report, recall B-0062-2021","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"T007984":[{"date":"2020-10-19","product":"RECOMBIVAX HB [Hepatitis B Vaccine (Recombinant)]","firm":"Merck Sharp & Dohme Corp.","distributor":false,"cls":"Class II","reason":"Merck's GARDASIL 9, PNEUMOVAX and RECOMBIVAX HB vaccines, stored at temperatures outside their respective temperature specifications, were subsequently distributed","area":"California","ref":"FDA Enforcement Report, recall B-0042-2021","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"S027047":[{"date":"2020-10-19","product":"PNEUMOVAX 23 (Pneumococcal Vaccine Polyvalent)","firm":"Merck Sharp & Dohme Corp.","distributor":false,"cls":"Class II","reason":"Merck's GARDASIL 9, PNEUMOVAX and RECOMBIVAX HB vaccines, stored at temperatures outside their respective temperature specifications, were subsequently distributed","area":"California","ref":"FDA Enforcement Report, recall B-0041-2021","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"R030456":[{"date":"2020-10-19","product":"GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) 10 Single-dose 05 mL Prefi…","firm":"Merck Sharp & Dohme Corp.","distributor":false,"cls":"Class II","reason":"Merck's GARDASIL 9, PNEUMOVAX and RECOMBIVAX HB vaccines, stored at temperatures outside their respective temperature specifications, were subsequently distributed","area":"California","ref":"FDA Enforcement Report, recall B-0040-2021","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"S036495":[{"date":"2020-10-19","product":"PNEUMOVAX 23","firm":"Merck","distributor":false,"cls":"","reason":"A limited number of units were stored at temperatures outside specification during shipment by a third-party delivery service to a McKesson facility; Merck advised another dose where a dose from affected units was given.","area":"Only units shipped from McKesson Chino, CA and received/administered on or after Aug 12, 2020 (provider level)","ref":"Manufacturer recall letter","url":"https://www.merckvaccines.com/wp-content/uploads/sites/8/2020/10/FINAL_Recall_19Oct2020_Letter_Pneumovax-23.pdf","kind":"Recall (voluntary)"}],"7000014":[{"date":"2019-06-20","product":"Cholera Vaccine Live Oral","firm":"PaxVax, Inc.","distributor":false,"cls":"Class III","reason":"Vaxchora, not meeting product specifications, was distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-0469-2020","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"159001":[{"date":"2017-07-28","product":"Bexsero Meningitis Vaccine, 0.5 mL single-dose pre-filled syringes, 60 vials/ 1 each per b…","firm":"MCKESSON MEDICAL","distributor":true,"cls":"Class III","reason":"Bexsero Meningitis Vaccine, lacking assurance of proper temperature maintenance during storage, was distributed.","area":"PA, NJ, VA","ref":"FDA Enforcement Report, recall B-0886-2017","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"M16095":[{"date":"2017-07-11","product":"Meningococcal [Groups A, C, Y, and W 135] Oligosaccharide Diphtheria CRM197 Conjugate Vacc…","firm":"GlaxoSmithKline Biologicals SA","distributor":false,"cls":"Class III","reason":"MENVEO [Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM(197) Conjugate Vaccine] Solution for intramuscular injection, associated with a mechanical intervention that is not supported by validation data, was distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-0705-2018","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"UI196AA":[{"date":"2015-04-21","product":"Sanofi Pasteur's 2014-2015 Fluzone Quadrivalent (Influenza Vaccine) Supplied in Multidose …","firm":"Sanofi Pasteur, Inc.","distributor":false,"cls":"Class III","reason":"Three lots of Sanofi Pasteur's 2014-2015 Fluzone Quadrivalent (Influenza Vaccine) supplied in Multidose vials, with antigen content that declined below the stability specification limit for two strains prior to product expiry, were distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-0042-16","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"UI190AC":[{"date":"2015-04-21","product":"Sanofi Pasteur's 2014-2015 Fluzone Quadrivalent (Influenza Vaccine) Supplied in Multidose …","firm":"Sanofi Pasteur, Inc.","distributor":false,"cls":"Class III","reason":"Three lots of Sanofi Pasteur's 2014-2015 Fluzone Quadrivalent (Influenza Vaccine) supplied in Multidose vials, with antigen content that declined below the stability specification limit for two strains prior to product expiry, were distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-0042-16","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"UI190AD":[{"date":"2015-04-21","product":"Sanofi Pasteur's 2014-2015 Fluzone Quadrivalent (Influenza Vaccine) Supplied in Multidose …","firm":"Sanofi Pasteur, Inc.","distributor":false,"cls":"Class III","reason":"Three lots of Sanofi Pasteur's 2014-2015 Fluzone Quadrivalent (Influenza Vaccine) supplied in Multidose vials, with antigen content that declined below the stability specification limit for two strains prior to product expiry, were distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-0042-16","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"2B472":[{"date":"2015-04-14","product":"FLULAVAL QUADRIVALENT","firm":"ID Biomedical Corp., a subsidary of GSK Biologicals","distributor":false,"cls":"Class III","reason":"Certain lots of FLULAVAL QUADRIVALENT, with observed loss of potency below the minimum specification prior to product expiry, were distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-0126-16","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"42N4L":[{"date":"2015-04-14","product":"FLULAVAL QUADRIVALENT","firm":"ID Biomedical Corp., a subsidary of GSK Biologicals","distributor":false,"cls":"Class III","reason":"Certain lots of FLULAVAL QUADRIVALENT, with observed loss of potency below the minimum specification prior to product expiry, were distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-0126-16","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"5AZ7H":[{"date":"2015-04-14","product":"FLULAVAL QUADRIVALENT","firm":"ID Biomedical Corp., a subsidary of GSK Biologicals","distributor":false,"cls":"Class III","reason":"Certain lots of FLULAVAL QUADRIVALENT, with observed loss of potency below the minimum specification prior to product expiry, were distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-0126-16","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"9A3ZM":[{"date":"2015-04-14","product":"FLULAVAL QUADRIVALENT","firm":"ID Biomedical Corp., a subsidary of GSK Biologicals","distributor":false,"cls":"Class III","reason":"Certain lots of FLULAVAL QUADRIVALENT, with observed loss of potency below the minimum specification prior to product expiry, were distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-0126-16","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"ZS95Z":[{"date":"2015-04-14","product":"FLULAVAL QUADRIVALENT","firm":"ID Biomedical Corp., a subsidary of GSK Biologicals","distributor":false,"cls":"Class III","reason":"Certain lots of FLULAVAL QUADRIVALENT, with observed loss of potency below the minimum specification prior to product expiry, were distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-0126-16","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"A2PK7":[{"date":"2015-04-14","product":"FLULAVAL QUADRIVALENT","firm":"ID Biomedical Corp., a subsidary of GSK Biologicals","distributor":false,"cls":"Class III","reason":"Certain lots of FLULAVAL QUADRIVALENT, with observed loss of potency below the minimum specification prior to product expiry, were distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-0126-16","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"AR57J":[{"date":"2015-04-14","product":"FLULAVAL QUADRIVALENT","firm":"ID Biomedical Corp., a subsidary of GSK Biologicals","distributor":false,"cls":"Class III","reason":"Certain lots of FLULAVAL QUADRIVALENT, with observed loss of potency below the minimum specification prior to product expiry, were distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-0126-16","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"DR4GF":[{"date":"2015-04-14","product":"FLULAVAL QUADRIVALENT","firm":"ID Biomedical Corp., a subsidary of GSK Biologicals","distributor":false,"cls":"Class III","reason":"Certain lots of FLULAVAL QUADRIVALENT, with observed loss of potency below the minimum specification prior to product expiry, were distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-0126-16","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"YF5DT":[{"date":"2015-04-14","product":"FLULAVAL QUADRIVALENT","firm":"ID Biomedical Corp., a subsidary of GSK Biologicals","distributor":false,"cls":"Class III","reason":"Certain lots of FLULAVAL QUADRIVALENT, with observed loss of potency below the minimum specification prior to product expiry, were distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-0126-16","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"F45C5":[{"date":"2015-04-14","product":"FLULAVAL QUADRIVALENT","firm":"ID Biomedical Corp., a subsidary of GSK Biologicals","distributor":false,"cls":"Class III","reason":"Certain lots of FLULAVAL QUADRIVALENT, with observed loss of potency below the minimum specification prior to product expiry, were distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-0126-16","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"T3J4S":[{"date":"2015-04-14","product":"FLULAVAL QUADRIVALENT","firm":"ID Biomedical Corp., a subsidary of GSK Biologicals","distributor":false,"cls":"Class III","reason":"Certain lots of FLULAVAL QUADRIVALENT, with observed loss of potency below the minimum specification prior to product expiry, were distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-0126-16","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"XP4J2":[{"date":"2015-04-14","product":"FLULAVAL QUADRIVALENT","firm":"ID Biomedical Corp., a subsidary of GSK Biologicals","distributor":false,"cls":"Class III","reason":"Certain lots of FLULAVAL QUADRIVALENT, with observed loss of potency below the minimum specification prior to product expiry, were distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-0126-16","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"379MY":[{"date":"2015-04-14","product":"FLULAVAL QUADRIVALENT","firm":"ID Biomedical Corp., a subsidary of GSK Biologicals","distributor":false,"cls":"Class III","reason":"Certain lots of FLULAVAL QUADRIVALENT, with observed loss of potency below the minimum specification prior to product expiry, were distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-0126-16","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"K009280":[{"date":"2014-10-17","product":"1 Single-Dose 0.7 mL Vial STERILE DILUENT For Merck Sharp & Dohme Corp., Live Virus Vaccin…","firm":"Merck & Co Inc","distributor":false,"cls":"Class III","reason":"A single lot of Sterile Diluent, with the potential for the lot number and expiry to be missing from the primary label, was distributed.","area":"OH","ref":"FDA Enforcement Report, recall B-0300-15","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"J007354":[{"date":"2013-12-19","product":"Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Recombinant Vaccine","firm":"Merck Sharpe & Dohme Corp","distributor":false,"cls":"Class II","reason":"GARDASIL, one lot with the potential for small glass particles to be present in the vial, was distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-0996-14","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"M12115":[{"date":"2013-12-02","product":"Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W135 Combined","firm":"NOVARTIS VACCINES AND DIAGNOSTICS S.r.l","distributor":false,"cls":"Class II","reason":"Lot of MENVEO Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM-197 Conjugate Vaccine, with higher than specified levels of residual moisture, was distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-0214-15","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"A12115":[{"date":"2013-12-02","product":"MENVEO","firm":"Novartis Vaccines and Diagnostics","distributor":false,"cls":"Class II","reason":"Higher-than-specified levels of residual moisture within the lyophilized MenA component vial; not expected to impact product quality; no action required for persons previously vaccinated.","area":"Customers asked to check inventory; 8,435 vials","ref":"FDA CBER recall notice (archived) + FDA Non-Blood On-Going Recalls page (class)","url":"http://web.archive.org/web/20170112095805/http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm377635.htm","kind":"Recall (voluntary, precautionary)"}],"X12115":[{"date":"2013-12-02","product":"MENVEO","firm":"Novartis Vaccines and Diagnostics","distributor":false,"cls":"Class II","reason":"Higher-than-specified levels of residual moisture within the lyophilized MenA component vial; not expected to impact product quality; no action required for persons previously vaccinated.","area":"Customers asked to check inventory; 8,435 vials","ref":"FDA CBER recall notice (archived) + FDA Non-Blood On-Going Recalls page (class)","url":"http://web.archive.org/web/20170112095805/http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm377635.htm","kind":"Recall (voluntary, precautionary)"}],"M12118":[{"date":"2013-07-10","product":"Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W135 Combined","firm":"NOVARTIS VACCINES AND DIAGNOSTICS S.r.l","distributor":false,"cls":"Class II","reason":"Lot of MENVEO Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM-197 Conjugate Vaccine, with higher than specified levels of residual moisture, was distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-1832-13","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"A12118":[{"date":"2013-07-03","product":"MENVEO","firm":"Novartis Vaccines and Diagnostics","distributor":false,"cls":"Class II","reason":"Higher-than-specified levels of residual moisture within the lyophilized MenA component vial.","area":"Customers; 70,170 vials","ref":"FDA CBER 2013 list (archived) + FDA Non-Blood On-Going Recalls page (class)","url":"http://web.archive.org/web/20161209074707/http://www.fda.gov:80/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm343834.htm","kind":"Recall (voluntary, precautionary)"}],"X12118":[{"date":"2013-07-03","product":"MENVEO","firm":"Novartis Vaccines and Diagnostics","distributor":false,"cls":"Class II","reason":"Higher-than-specified levels of residual moisture within the lyophilized MenA component vial.","area":"Customers; 70,170 vials","ref":"FDA CBER 2013 list (archived) + FDA Non-Blood On-Going Recalls page (class)","url":"http://web.archive.org/web/20161209074707/http://www.fda.gov:80/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm343834.htm","kind":"Recall (voluntary, precautionary)"}],"J001183":[{"date":"2013-06-26","product":"Hepatitis B Vaccine (Recombinant)","firm":"Merck Sharpe & Dohme Corp","distributor":false,"cls":"Class II","reason":"Recombivax HB, one lot with the potential for a crack to have occurred in the vial, was distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-0625-14","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"E12871":[{"date":"2012-09-25","product":"Typhoid Vi Polysaccharide Vaccine","firm":"Sanofi Pasteur, Inc.","distributor":false,"cls":"Class III","reason":"Lots of Typhim Vi (Typhoid Vi Polysaccharide Vaccine), with potentially low antigen content, were distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-2189-13","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"E12881":[{"date":"2012-09-25","product":"Typhoid Vi Polysaccharide Vaccine","firm":"Sanofi Pasteur, Inc.","distributor":false,"cls":"Class III","reason":"Lots of Typhim Vi (Typhoid Vi Polysaccharide Vaccine), with potentially low antigen content, were distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-2189-13","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"G04811":[{"date":"2012-09-25","product":"Typhoid Vi Polysaccharide Vaccine","firm":"Sanofi Pasteur, Inc.","distributor":false,"cls":"Class III","reason":"Lots of Typhim Vi (Typhoid Vi Polysaccharide Vaccine), with potentially low antigen content, were distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-2189-13","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"G05071":[{"date":"2012-09-25","product":"Typhoid Vi Polysaccharide Vaccine","firm":"Sanofi Pasteur, Inc.","distributor":false,"cls":"Class III","reason":"Lots of Typhim Vi (Typhoid Vi Polysaccharide Vaccine), with potentially low antigen content, were distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-2189-13","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"G05081":[{"date":"2012-09-25","product":"Typhoid Vi Polysaccharide Vaccine","firm":"Sanofi Pasteur, Inc.","distributor":false,"cls":"Class III","reason":"Lots of Typhim Vi (Typhoid Vi Polysaccharide Vaccine), with potentially low antigen content, were distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-2189-13","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"G11301":[{"date":"2012-09-25","product":"Typhoid Vi Polysaccharide Vaccine","firm":"Sanofi Pasteur, Inc.","distributor":false,"cls":"Class III","reason":"Lots of Typhim Vi (Typhoid Vi Polysaccharide Vaccine), with potentially low antigen content, were distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-2189-13","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"M10135B":[{"date":"2012-08-01","product":"Labeled in part: ***Meningococcal***Groups A, C, Y and W-135***Oligosaccharide***Diphtheri…","firm":"PSS World Medical Shared Services","distributor":true,"cls":"Class III","reason":"Meningococcal Oligosaccharide Diphtheria Conjugate Vaccine, with lack of assurance of proper temperature maintenance during shipment, was distributed.","area":"TX, MA, AZ and CA","ref":"FDA Enforcement Report, recall B-0894-13","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"0851AA":[{"date":"2012-06-12","product":"Measles, Mumps and Rubella Virus Vaccine Live","firm":"Merck Sharpe & Dohme Corp","distributor":false,"cls":"Class III","reason":"M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live)was inadvertently distributed.","area":"Multiple U.S. States","ref":"FDA Enforcement Report, recall B-2190-13","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"YL2077":[{"date":"2012-02-28","product":"FluMist, Influenza Virus Vaccine, Live, Intranasal, each 0.2mL dose is a suspension suppli…","firm":"MedImmune, LLC","distributor":false,"cls":"Class III","reason":"FluMist, Influenza Virus Vaccine, Live Intranasal, lacking assurance of proper temperature manintenance during shipment, was distributed.","area":"Product was distributed within the US to CA, FL and TX.  Government account:  Department of Defense, Camp Pendleton, CA.","ref":"FDA Enforcement Report, recall B-2586-12","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm","kind":"Recall"}],"F73652":[{"date":"2012-02-10","product":"Prevnar 13","firm":"Pfizer","distributor":false,"cls":"","reason":"Pfizer initiated the recall when it was determined the lot was formulated and filled with expired serotype 3 conjugate material (FDA list).","area":"Per Pfizer (AP report): recalled from one wholesaler; none distributed to health care providers","ref":"FDA CBER 2012 list (event, reason); lot number from secondary news (secondary source only)","url":"http://web.archive.org/web/20161209074701/http://www.fda.gov:80/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm290484.htm","kind":"Recall (voluntary)"}],"111812P1":[{"date":"2010-12-17","product":"FLUVIRIN","firm":"Novartis Vaccines and Diagnostics","distributor":false,"cls":"","reason":"Cracked vial necks leading to broken vials detected in a small number of vials; cracks carry potential risk of compromised sterility. Notice states patients previously vaccinated without problems need no further action such as revaccination.","area":"Consignees asked to check inventory, stop using and return vials from this lot","ref":"FDA CBER recall notice (archived)","url":"http://web.archive.org/web/20161023023411/http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm238117.htm","kind":"Recall (voluntary)"}],"458011A":[{"date":"2010-04-13","product":"RabAvert","firm":"Novartis Vaccines and Diagnostics","distributor":false,"cls":"","reason":"Stopper and metal crimp can dislodge from the diluent vial when removing the protective cap (low percentage of diluent vials). Lyophilized vaccine vial not affected; no revaccination required per notice.","area":"Customers asked to return complete kits","ref":"FDA CBER notice (archived)","url":"http://web.archive.org/web/20161023023427/http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm208973.htm","kind":"Market withdrawal (voluntary)"}],"927011":[{"date":"2010-04-13","product":"RabAvert","firm":"Novartis Vaccines and Diagnostics","distributor":false,"cls":"","reason":"Stopper and metal crimp can dislodge from the diluent vial when removing the protective cap (low percentage of diluent vials). Lyophilized vaccine vial not affected; no revaccination required per notice.","area":"Customers asked to return complete kits","ref":"FDA CBER notice (archived)","url":"http://web.archive.org/web/20161023023427/http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm208973.htm","kind":"Market withdrawal (voluntary)"}],"E25197":[{"date":"2010-03-22","product":"Prevnar (PCV7)","firm":"Wyeth (Pfizer)","distributor":false,"cls":"","reason":"Potential for syringes to have been distributed with a rubber formulation in the syringe tip caps that was not approved for use with Prevnar. Wyeth concluded no health or safety risk, no expected loss of potency, and no need to revaccinate.","area":"Customers asked to contact manufacturer to return product","ref":"FDA CBER recall notice (archived)","url":"http://web.archive.org/web/20161023023430/http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm206288.htm","kind":"Recall (voluntary)"}],"E28211":[{"date":"2010-03-22","product":"Prevnar (PCV7)","firm":"Wyeth (Pfizer)","distributor":false,"cls":"","reason":"Potential for syringes to have been distributed with a rubber formulation in the syringe tip caps that was not approved for use with Prevnar. Wyeth concluded no health or safety risk, no expected loss of potency, and no need to revaccinate.","area":"Customers asked to contact manufacturer to return product","ref":"FDA CBER recall notice (archived)","url":"http://web.archive.org/web/20161023023430/http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm206288.htm","kind":"Recall (voluntary)"}],"E37556":[{"date":"2010-03-22","product":"Prevnar (PCV7)","firm":"Wyeth (Pfizer)","distributor":false,"cls":"","reason":"Potential for syringes to have been distributed with a rubber formulation in the syringe tip caps that was not approved for use with Prevnar. Wyeth concluded no health or safety risk, no expected loss of potency, and no need to revaccinate.","area":"Customers asked to contact manufacturer to return product","ref":"FDA CBER recall notice (archived)","url":"http://web.archive.org/web/20161023023430/http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm206288.htm","kind":"Recall (voluntary)"}],"E38749":[{"date":"2010-03-22","product":"Prevnar (PCV7)","firm":"Wyeth (Pfizer)","distributor":false,"cls":"","reason":"Potential for syringes to have been distributed with a rubber formulation in the syringe tip caps that was not approved for use with Prevnar. Wyeth concluded no health or safety risk, no expected loss of potency, and no need to revaccinate.","area":"Customers asked to contact manufacturer to return product","ref":"FDA CBER recall notice (archived)","url":"http://web.archive.org/web/20161023023430/http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm206288.htm","kind":"Recall (voluntary)"}],"UT023AA":[{"date":"2010-02-03","product":"Influenza A (H1N1) 2009 Monovalent Vaccine (prefilled syringes)","firm":"Sanofi Pasteur","distributor":false,"cls":"","reason":"Prefilled syringes; routine stability testing determined that those lots no longer met the potency specification.","area":"Not stated in FDA summary","ref":"FDA CBER 2010 Biologics Recalls list (archived); individual notice ucm200665 not archived","url":"http://web.archive.org/web/20161209074622/http://www.fda.gov:80/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm245090.htm","kind":"Recall (voluntary)"}],"UT023BA":[{"date":"2010-02-03","product":"Influenza A (H1N1) 2009 Monovalent Vaccine (prefilled syringes)","firm":"Sanofi Pasteur","distributor":false,"cls":"","reason":"Prefilled syringes; routine stability testing determined that those lots no longer met the potency specification.","area":"Not stated in FDA summary","ref":"FDA CBER 2010 Biologics Recalls list (archived); individual notice ucm200665 not archived","url":"http://web.archive.org/web/20161209074622/http://www.fda.gov:80/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm245090.htm","kind":"Recall (voluntary)"}],"UT023CA":[{"date":"2010-02-03","product":"Influenza A (H1N1) 2009 Monovalent Vaccine (prefilled syringes)","firm":"Sanofi Pasteur","distributor":false,"cls":"","reason":"Prefilled syringes; routine stability testing determined that those lots no longer met the potency specification.","area":"Not stated in FDA summary","ref":"FDA CBER 2010 Biologics Recalls list (archived); individual notice ucm200665 not archived","url":"http://web.archive.org/web/20161209074622/http://www.fda.gov:80/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm245090.htm","kind":"Recall (voluntary)"}],"UT023EA":[{"date":"2010-02-03","product":"Influenza A (H1N1) 2009 Monovalent Vaccine (prefilled syringes)","firm":"Sanofi Pasteur","distributor":false,"cls":"","reason":"Prefilled syringes; routine stability testing determined that those lots no longer met the potency specification.","area":"Not stated in FDA summary","ref":"FDA CBER 2010 Biologics Recalls list (archived); individual notice ucm200665 not archived","url":"http://web.archive.org/web/20161209074622/http://www.fda.gov:80/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm245090.htm","kind":"Recall (voluntary)"}],"UT023FA":[{"date":"2010-02-03","product":"Influenza A (H1N1) 2009 Monovalent Vaccine (prefilled syringes)","firm":"Sanofi Pasteur","distributor":false,"cls":"","reason":"Prefilled syringes; routine stability testing determined that those lots no longer met the potency specification.","area":"Not stated in FDA summary","ref":"FDA CBER 2010 Biologics Recalls list (archived); individual notice ucm200665 not archived","url":"http://web.archive.org/web/20161209074622/http://www.fda.gov:80/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm245090.htm","kind":"Recall (voluntary)"}],"UT023DA":[{"date":"2009-12-16","product":"Influenza A (H1N1) 2009 Monovalent Vaccine (pediatric 0.25 mL)","firm":"Sanofi Pasteur","distributor":false,"cls":"","reason":"Routine testing identified four distributed lots with lower antigen content than the specification limit. FDA and CDC stated there were no safety concerns and did not recommend repeating doses.","area":"Providers asked to stop using and return remaining inventory","ref":"FDA CBER recall notice (archived)","url":"http://web.archive.org/web/20161023023439/http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm195333.htm","kind":"Recall (voluntary)"}],"UT028CB":[{"date":"2009-12-16","product":"Influenza A (H1N1) 2009 Monovalent Vaccine (pediatric 0.25 mL)","firm":"Sanofi Pasteur","distributor":false,"cls":"","reason":"Routine testing identified four distributed lots with lower antigen content than the specification limit. FDA and CDC stated there were no safety concerns and did not recommend repeating doses.","area":"Providers asked to stop using and return remaining inventory","ref":"FDA CBER recall notice (archived)","url":"http://web.archive.org/web/20161023023439/http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm195333.htm","kind":"Recall (voluntary)"}],"UT028DA":[{"date":"2009-12-16","product":"Influenza A (H1N1) 2009 Monovalent Vaccine (pediatric 0.25 mL)","firm":"Sanofi Pasteur","distributor":false,"cls":"","reason":"Routine testing identified four distributed lots with lower antigen content than the specification limit. FDA and CDC stated there were no safety concerns and did not recommend repeating doses.","area":"Providers asked to stop using and return remaining inventory","ref":"FDA CBER recall notice (archived)","url":"http://web.archive.org/web/20161023023439/http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm195333.htm","kind":"Recall (voluntary)"}],"UT030CA":[{"date":"2009-12-16","product":"Influenza A (H1N1) 2009 Monovalent Vaccine (pediatric 0.25 mL)","firm":"Sanofi Pasteur","distributor":false,"cls":"","reason":"Routine testing identified four distributed lots with lower antigen content than the specification limit. FDA and CDC stated there were no safety concerns and did not recommend repeating doses.","area":"Providers asked to stop using and return remaining inventory","ref":"FDA CBER recall notice (archived)","url":"http://web.archive.org/web/20161023023439/http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm195333.htm","kind":"Recall (voluntary)"}]}}