Atorvastatin Calcium Tablets USP 20 mg* Rx Only — Class II drug recall D-0372-2023
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-0372-2023 |
|---|---|
| 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 | 241,585 bottles |
| Reason classes | cgmp |
| UPC / GTIN / UDI-DI | 00316729045155, 00316729045179 |
| NDC | 16729-0044, 16729-0044-01, 16729-0044-10, 16729-0044-15, 16729-0044-16, 16729-0044-17, 16729-0045, 16729-0045-01, 16729-0045-10, 16729-0045-15, 16729-0045-16, 16729-0045-17, 16729-0046, 16729-0046-01, 16729-0046-10, 16729-0046-15, 16729-0046-16, 16729-0046-17, 16729-0047, 16729-0047-01, 16729-0047-10, 16729-0047-15, 16729-0047-16, 16729-0047-17 |
| Expiration dates | 2023-02-28, 2023-10-31, 2023-12-31, 2024-01-31, 2024-02-29, 2024-03-31, 2024-06-30 |
Product
Atorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-045-15 UPC 3 16729 04515 5; b) 1,000 Tablets NDC 16729-045-17 UPC 3 16729 04517 9, 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-0372-2023. 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.