FDA Drug recall D-817-2013
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc.,…
- FDA Drug
- Class II
- terminated
- Published 2013-07-31
On 2013-07-31 the FDA classified a Class II recall of Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc.,… by Watson Laboratories Actavis Florida, citing failed Tablet/Capsule Specifications: Broken tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-817-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-22 |
| Published | 2013-07-31 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Watson Laboratories Actavis Florida |
| Distribution | US |
Product
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60
Reason
Failed Tablet/Capsule Specifications: Broken tablets
Identifiers
| ndc | 0591-0397-60 |
|---|---|
| ndc | 0591-0397-19 |
| ndc | 0591-0398-60 |
| code_info | Lot 635098A, Exp 10/14 |
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-817-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.