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Recall Enforment Report D-0883-2022

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Cardinal Health Inc., originally initiated on 04-05-2022 for the product Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 00002-1434-80 The product was recalled due to temperature abuse: products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.. The product was distributed in Nm Only and the recall is currently completed.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0883-202204-05-202205-25-2022Class II1 boxTrulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 00002-1434-80TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.Completed
D-0884-202204-05-202205-25-2022Class II1 boxTrulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditionsCompleted
D-0882-202204-05-202205-25-2022Class I1 boxHumalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly USA, LLC, Indianapolis, IN 46285, Box NDC 0002-8799-59, Pen NDC 002-7516-59TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.Completed

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0002-0800 DiluentInjection, SolutionEli Lilly And CompanyDrug For Further Processing
0002-0800Sterile Diluent DiluentInjection, SolutionSubcutaneousEli Lilly And CompanyHuman Prescription Drug
0002-1433Trulicity DulaglutideInjection, SolutionSubcutaneousEli Lilly And CompanyHuman Prescription Drug
0002-1434Trulicity DulaglutideInjection, SolutionSubcutaneousEli Lilly And CompanyHuman Prescription Drug
0002-2236Trulicity DulaglutideInjection, SolutionSubcutaneousEli Lilly And CompanyHuman Prescription Drug
0002-3182Trulicity DulaglutideInjection, SolutionSubcutaneousEli Lilly And CompanyHuman Prescription Drug
0002-7510Humalog Insulin LisproInjection, SolutionIntravenous; SubcutaneousEli Lilly And CompanyHuman Prescription Drug
0002-7516Humalog Insulin LisproInjection, SolutionIntravenous; SubcutaneousEli Lilly And CompanyHuman Prescription Drug
0002-7533Humalog Insulin LisproInjection, SolutionIntravenous; SubcutaneousEli Lilly And CompanyHuman Prescription Drug
0002-7712Humalog KwikPenInsulin LisproInjection, SolutionSubcutaneousEli Lilly And CompanyHuman Prescription Drug
0002-7714Humalog Junior KwikPenInsulin LisproInjection, SolutionSubcutaneousEli Lilly And CompanyHuman Prescription Drug
0002-8208Humalog Tempo PenInsulin LisproInjection, SolutionSubcutaneousEli Lilly And CompanyHuman Prescription Drug
0002-8213Humalog Tempo PenInsulin LisproInjection, SolutionSubcutaneousEli Lilly And CompanyHuman Prescription Drug
0002-8799Humalog KwikPenInsulin LisproInjection, SolutionIntravenous; SubcutaneousEli Lilly And CompanyHuman Prescription Drug