Multi event Drug Recall Enforcement Report Class II voluntary initiated by Actavis Laboratories, FL, Inc., originally initiated on 04-24-2014 for the 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. The product was recalled due to failed tablet/capsule specifications: recall due to complaints of split or broken tablets.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-1616-2014 | 04-24-2014 | 10-08-2014 | Class II | 36,538 bottles | 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. | Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. | Terminated |
| D-1617-2014 | 04-24-2014 | 10-08-2014 | Class II | 6,041 bottles | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0397-60, UPC 3 05910 39760 9. | Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. | Terminated |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 0591-0397 | Diclofenac Sodium And Misoprostol | Diclofenac Sodium And Misoprostol | Tablet, Delayed Release | Oral | Actavis Pharma, Inc. | Human Prescription Drug |
| 0591-0398 | Diclofenac Sodium And Misoprostol | Diclofenac Sodium And Misoprostol | Tablet, Delayed Release | Oral | Actavis Pharma, Inc. | Human Prescription Drug |
