FDA Drug recall D-1701-2012
NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, I…
- FDA Drug
- Class II
- terminated
- Published 2012-10-03
On 2012-10-03 the FDA classified a Class II recall of NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, I… by Glenmark Generics Usa, citing labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1701-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-06 |
| Published | 2012-10-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Glenmark Generics Usa |
| Distribution | US |
Product
NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430; NDC 68462-190-01.
Reason
Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.
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 | Lot #: 02112930, 02112934, 02112941, Exp 09/14; 2112985, 02112986, 02113334, Exp 10/14; 02113360, 02113372, 02113420, 02113606, 02113663, 02113664, Exp 11/14. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1701-2012%22
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