FDA Drug recall D-1082-2014
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, In…
- FDA Drug
- Class II
- terminated
- Published 2014-02-19
On 2014-02-19 the FDA classified a Class II recall of Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, In… by Watson Laboratories Actavis Florida, citing failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1082-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-20 |
| Published | 2014-02-19 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Watson Laboratories Actavis Florida |
| Distribution | US |
Product
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6.
Reason
Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.
Identifiers
| upc | 305910398606 |
|---|---|
| ndc | 0591-0397-60 |
| ndc | 0591-0397-19 |
| ndc | 0591-0398-60 |
| code_info | Lot# 605957A, Exp 09/14 |
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-1082-2014%22
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