FDA Drug recall D-1616-2014
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 2014-10-08
On 2014-10-08 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 Actavis Laboratories Fl, citing failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1616-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-24 |
| Published | 2014-10-08 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Actavis Laboratories Fl |
| 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: Recall due to complaints of split or broken tablets.
Identifiers
| upc | 305910398606 |
|---|---|
| ndc | 0591-0397-60 |
| ndc | 0591-0397-19 |
| ndc | 0591-0398-60 |
| code_info | Lot #: 605956A, 605958A, Exp. 9/30/2014; 644678M, Exp. 10/31/2014; 661841A, Exp. 11/30/2014; 717469A, Exp 2/28/2015 |
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-1616-2014%22
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