FDA Drug recall D-0258-2015
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only
- FDA Drug
- Class II
- terminated
- Published 2014-12-03
On 2014-12-03 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 by Actavis Laboratories Fl, citing failed Tablet/Capsule Specifications: Presence of split or broken tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0258-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-26 |
| Published | 2014-12-03 |
| 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: Presence of split or broken tablets.
Identifiers
| upc | 305910398606 |
|---|---|
| ndc | 0591-0397-60 |
| ndc | 0591-0397-19 |
| ndc | 0591-0398-60 |
| code_info | Lot # 694320A, Expiry: 02/28/2015. |
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-0258-2015%22
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