Drug recall D-1616-2014
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 for recall
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Lots and codes
Lot #: 605956A, 605958A, Exp. 9/30/2014; 644678M, Exp. 10/31/2014; 661841A, Exp. 11/30/2014; 717469A, Exp 2/28/2015
Recall details
- Recalling firm
- Actavis Laboratories, FL, Inc., Davie, FL
- Quantity
- 36,538 bottles
- Distribution
- Nationwide and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 24, 2014
- Terminated
- December 23, 2016
Related products
- Diclofenac sodium and Misoprostol – drug information
- NDC 0591-0397 Diclofenac Sodium and Misoprostol · Diclofenac Sodium 50 mg/1; Misoprostol 200 ug/1 · Actavis Pharma, Inc.
- NDC 0591-0398 Diclofenac Sodium and Misoprostol · Diclofenac Sodium 75 mg/1; Misoprostol 200 ug/1 · Actavis Pharma, Inc.