FDA Drug recall D-0822-2021
Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufac…
- FDA Drug
- Class II
- terminated
- Published 2021-09-29
On 2021-09-29 the FDA classified a Class II recall of Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufac… by Glenmark Pharmaceuticals Usa, citing CGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0822-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-27 |
| Published | 2021-09-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
Product
Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Tablets NDC 68462-179-01; b) 500 Tablets NDC 68462-179-05
Reason
CGMP Deviations
Identifiers
| ndc | 68462-188-01 |
|---|---|
| ndc | 68462-188-05 |
| ndc | 68462-189-01 |
| ndc | 68462-189-05 |
| ndc | 68462-190-30 |
| ndc | 68462-190-50 |
| ndc | 68462-190-01 |
| ndc | 68462-190-05 |
| ndc | 68462-178-01 |
| ndc | 68462-178-05 |
| ndc | 68462-179-01 |
| ndc | 68462-179-05 |
| code_info | Lots: a) 29190082 Exp. 09/30/2021; 29190083 Exp. 09/30/2021; 29190084 Exp. 10/31/2021; 29190085 Exp. 10/31/2021; 292000…Lots: a) 29190082 Exp. 09/30/2021; 29190083 Exp. 09/30/2021; 29190084 Exp. 10/31/2021; 29190085 Exp. 10/31/2021; 29200001 Exp. 12/31/2021; 29200003 Exp. 01/31/2022; 29200004 Exp. 01/31/2022; 29200005 Exp. 01/31/2022; 29200012 Exp. 02/28/2022; 29200013 Exp. 02/28/2022; b) 29200010 Exp. 02/28/2022 |
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-0822-2021%22
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