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Insulin

FDA recalls

6 rows

DateCompany and reasonClass
Mar 11, 2024Eli Lilly & Company
CGMP Deviations
Class II · Completed
Apr 10, 2023Sanofi-Aventis U.S. LLC
Lack of Assurance of Sterility: Malformed crimped collar seal
Class II · Ongoing
Apr 4, 2022Cardinal Health Inc.
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Class I · Completed
Mar 21, 2021Novo Nordisk Inc
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Class I · Terminated
Mar 21, 2021Novo Nordisk Inc
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Class I · Terminated
Jul 4, 2018Sanofi-Aventis U.S. LLC
Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
Class II · Ongoing

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).