INSULIN HUMAN Recall D-0445-2024
Description: Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-100, 10 mL, Use ONLY with Insulins listed on carton, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285. NDC: 0002-0800-01
INSULIN HUMAN Recall D-0445-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0445-2024 |
| Event ID | 94214 |
| Brand | HUMULIN |
| Generic Name | INSULIN HUMAN |
| Manufacturer | INSULIN HUMAN |
| Original Package? | 1 |
| Active Substance | INSULIN HUMAN |
| Drug Route | SUBCUTANEOUS |
| Distribution | Nationwide USA |
| Quantity | 700 vials |
| Recall Reason | CGMP Deviations |
| Drug Classification | Class II |
| Drug Code Info | 20240424 |
| Product NDC | 0002-8315 0002-8805 0002-0800 |
| Product NUI | M0011417 N0000175944 |
| Pharma Class (EPC) | Insulin [EPC] |
| Pharma Class (CS) | Insulin [CS] |
| Recall Initiation Date | 20240312 |
| Report Date | 20240424 |
| Classification Date | 20240417 |
| Address | 893 S Delaware St Indianapolis, IN 46225-1782 United States |
| Recalling Firm | Eli Lilly & Company |
| Initial Notification | |
| Unique Ingredient Identifier | 059QF0KO0R 1Y17CTI5SR |
| Drug Application Number | BLA018781 |
| Structured Product Labeling (SPL ID) | dec32ead-837e-4331-ab55-f3bbccea5b38 |
| Structured Product Labeling (SPL Set ID) | f6edd793-440b-40c2-96b5-c16133b7a921 |
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