Product Safety Recalls

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INSULIN LISPRO Recall D-0882-2022

Description: Humalog 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 002-7516-59

INSULIN LISPRO Recall D-0882-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0882-2022
Event ID89976
Original Package?1
Active SubstanceINSULIN LISPRO
DistributionNM only
Quantity1 box
Recall ReasonTEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Drug ClassificationClass I
Drug Code Info20220525
Product NDC0002-8799 0002-7510 0002-7516
Product NUIN0000004931 N0000175453
Drug UPC0300027510019
Pharma Class (EPC)Insulin Analog [EPC]
Pharma Class (CS)Insulin [Chemical/Ingredient]
Recall Initiation Date20220405
Report Date20220525
Classification Date20220519
Address7000 Cardinal Pl
Dublin, OH 43017-1091
United States
Recalling FirmCardinal Health Inc.
Initial Notification Letter
Unique Ingredient IdentifierGFX7QIS1II
Drug Application NumberBLA020563
Structured Product Labeling (SPL ID)28413b62-921e-4eb4-bd8b-cf17d752a448
Structured Product Labeling (SPL Set ID)c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f
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