Drug 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.
D-1616-2014
Product summary
- Event
- Event 69237
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36,538 bottles
- Official record key
drug-enforcement:D-1616-2014
Official wording
Reason: Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Code information: Lot #: 605956A, 605958A, Exp. 9/30/2014; 644678M, Exp. 10/31/2014; 661841A, Exp. 11/30/2014; 717469A, Exp 2/28/2015
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.