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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