FDA Drug recall D-0373-2023
Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-046-15 UPC 3 16729 04615 2
- FDA Drug
- Class II
- terminated
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class II recall of Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-046-15 UPC 3 16729 04615 2 by Accord Healthcare, citing CGMP Deviations: recalling drug products following an FDA inspection.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0373-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-02-07 |
| Published | 2023-03-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Accord Healthcare |
| Distribution | PR |
Product
Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-046-15 UPC 3 16729 04615 2; b) 1,000 Tablets NDC 16729-046-17 UPC 3 16729 04617 6, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Identifiers
| upc | 316729046152 |
|---|---|
| upc | 316729046176 |
| ndc | 16729-045-10 |
| ndc | 16729-045-15 |
| ndc | 16729-045-01 |
| ndc | 16729-045-16 |
| ndc | 16729-045-17 |
| ndc | 16729-044-10 |
| ndc | 16729-044-15 |
| ndc | 16729-044-01 |
| ndc | 16729-044-16 |
| ndc | 16729-044-17 |
| ndc | 16729-046-10 |
| ndc | 16729-046-15 |
| ndc | 16729-046-01 |
| ndc | 16729-046-16 |
| ndc | 16729-046-17 |
| ndc | 16729-047-10 |
| ndc | 16729-047-15 |
| ndc | 16729-047-01 |
| ndc | 16729-047-16 |
| ndc | 16729-047-17 |
| code_info | Batches: a)R2100552, R2100553, Exp. Date 4/30/2023; R2200253, Exp. Date 2/29/2024; R2200627, Exp. Date 4/30/2024; R2201…Batches: a)R2100552, R2100553, Exp. Date 4/30/2023; R2200253, Exp. Date 2/29/2024; R2200627, Exp. Date 4/30/2024; R2201113, Exp. Date 6/30/2024; R2201184, Exp. Date 8/31/2024; R2201366, Exp. Date 9/30/2024; b) R2200280, Exp. Date 2/29/2024; R2200385, R2200386, R2200491, R2200490, R2200494, R2200496, R2200495, Exp. Date 3/31/2024; R2200510, R2200520, R2200521, R2200517, R2200511, R2200632, R2200631, R2200637, R2200635, R2200648, R2200638, R2200639, R2200647, Exp. Date 4/30/2024; R2200727, Exp. Date 5/31/2024; |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0373-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.