FDA Drug recall D-0380-2023
Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC 16729-218-10 UPC 3 16729 21810 8
- FDA Drug
- Class II
- terminated
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class II recall of Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC 16729-218-10 UPC 3 16729 21810 8 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-0380-2023 |
| 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
Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC 16729-218-10 UPC 3 16729 21810 8; b) 90-count bottles NDC 16729-218-15 UPC 3 16729 21815 3; c) 500-count bottles, NDC 16729-218-16, UPC 3 16729 21816 0; 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 | 316729218108 |
|---|---|
| upc | 316729218153 |
| upc | 316729218160 |
| code_info | Batches: a) P2001925, Exp. Date 3/31/2023; P2003532, Exp. Date 6/30/2023; P2004847, Exp. Date 7/31/2023; R2000856, Exp.…Batches: a) P2001925, Exp. Date 3/31/2023; P2003532, Exp. Date 6/30/2023; P2004847, Exp. Date 7/31/2023; R2000856, Exp. Date 11/30/2023; P2100452, Exp. Date 12/31/2023; P2100898, Exp. Date 1/31/2024; P2106273, Exp. Date 9/30/2024; b) R2000578, Exp. Date 7/31/2023; R2000653, Exp. Date 9/30/2023; R2000652, Exp. Date 9/30/2023; R2000826, Exp. Date 10/31/2023; R2000852, Exp. Date 10/31/2023; R2000853, Exp. Date 10/31/2023; R2000827, Exp. Date 11/30/2023; P2100102, Exp. Date,12/31/2023; P2100004, Exp. Date 12/31/2023; P2100450, Exp. Date 12/31/2023; P2100449, Exp. Date 12/31/2023; c)P2001392, P2001393, P2001395, P2001396, P2001397, P2001492, P2001493, P2001494, P2001495, Exp. Date 2/28/2023; P2001863, P2001864, P2001865, P2001924, P2001866, P2001926, P2001927, P2002072, P2002073, P2002071, P2002074, P2002075, P2002392, Exp. Date 3/31/2023; P2002230, P2002233, P2002234, P2002235, P2002274, P2002400, P2002399, P2002398, P2002479, P2002478, P2002481, P2002480, P2002482, P2002483, Exp. Date |
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-0380-2023%22
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