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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0882-2022 |
Event ID | 89976 |
Brand | HUMALOG |
Generic Name | INSULIN LISPRO |
Manufacturer | INSULIN LISPRO |
Original Package? | 1 |
Active Substance | INSULIN LISPRO |
Drug Route | INTRAVENOUS |
Distribution | NM only |
Quantity | 1 box |
Recall Reason | TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather. |
Drug Classification | Class I |
Drug Code Info | 20220525 |
Product NDC | 0002-8799 0002-7510 0002-7516 |
Product NUI | N0000004931 N0000175453 |
Drug UPC | 0300027510019 |
Pharma Class (EPC) | Insulin Analog [EPC] |
Pharma Class (CS) | Insulin [Chemical/Ingredient] |
Recall Initiation Date | 20220405 |
Report Date | 20220525 |
Classification Date | 20220519 |
Address | 7000 Cardinal Pl Dublin, OH 43017-1091 United States |
Recalling Firm | Cardinal Health Inc. |
Initial Notification | Letter |
Unique Ingredient Identifier | GFX7QIS1II |
Drug Application Number | BLA020563 |
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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