SIMVASTATIN Recall D-0411-2023
Description: Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15, UPC 3 16729 00615 6; b) 1,000-count tablets NDC 16729-006-17, UPC 3 16729 00617 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
SIMVASTATIN Recall D-0411-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0411-2023 |
| Event ID | 91657 |
| Brand | SIMVASTATIN |
| Generic Name | SIMVASTATIN |
| Manufacturer | SIMVASTATIN |
| Original Package? | 1 |
| Active Substance | SIMVASTATIN |
| Drug Route | ORAL |
| Distribution | United States including Puerto Rico and Canada |
| Quantity | 1,190,484 bottles |
| Recall Reason | CGMP Deviations: recalling drug products following an FDA inspection. |
| Drug Classification | Class II |
| Drug Code Info | 20230308 |
| Product NDC | 16729-004 16729-005 16729-006 |
| Product NUI | N0000175589 N0000000121 |
| Drug UPC | 0316729156103 316729006156 316729006170 |
| Pharma Class (EPC) | HMG-CoA Reductase Inhibitor [EPC] |
| Recall Initiation Date | 20230207 |
| Report Date | 20230308 |
| Classification Date | 20230302 |
| Address | 1009 Slater Rd Ste 210B Durham, NC 27703-8446 United States |
| Recalling Firm | Accord Healthcare, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | AGG2FN16EV |
| Drug Application Number | ANDA078155 |
| Structured Product Labeling (SPL ID) | ed1b03bb-2300-1f49-e053-2995a90a0052 |
| Structured Product Labeling (SPL Set ID) | 871251c0-36a1-4a32-9eab-ff6c1e925ca9 |
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