Simvastatin Tablets USP 5 mg Rx Only — Class II drug recall D-0408-2023
Terminated recall by Accord Healthcare, Inc., reported 2023-03-08, distributed in PR. CGMP Deviations: recalling drug products following an FDA inspection.
| Recall number | D-0408-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accord Healthcare, Inc., Durham, NC, United States |
| Recall initiated | 2023-02-07 |
| Classified | 2023-03-02 |
| Reported by FDA | 2023-03-08 |
| Terminated | 2024-04-22 |
| Distributed | PR |
| Countries outside the US | CA |
| Quantity | 256,648 bottles |
| Reason classes | cgmp |
| UPC / GTIN / UDI-DI | 00316729156158, 00316729156172 |
| NDC | 16729-0004, 16729-0004-10, 16729-0004-12, 16729-0004-15, 16729-0004-17, 16729-0005, 16729-0005-10, 16729-0005-12, 16729-0005-15, 16729-0005-17, 16729-0006, 16729-0006-10, 16729-0006-12, 16729-0006-15, 16729-0006-17, 16729-0007, 16729-0007-10, 16729-0007-12, 16729-0007-15, 16729-0007-17, 16729-0156, 16729-0156-10, 16729-0156-15, 16729-0156-17 |
| Expiration dates | 2023-06-30, 2023-09-30, 2023-10-31, 2025-04-30, 2025-05-31 |
Product
Simvastatin Tablets USP 5 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-156-15, UPC 3 16729 15615 8; b) 1,000-count bottle NDC 16729-156-17, UPC 3 16729 15617 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
Reason for recall
CGMP Deviations: recalling drug products following an FDA inspection.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0408-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.