Drug product
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.
D-1617-2014
Product summary
- Event
- Event 69237
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,041 bottles
- Official record key
drug-enforcement:D-1617-2014
Official wording
Reason: Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Code information: Lot #: 660513A, Exp. 10/31/2014
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.