Drug recall D-1082-2014
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: Split tablets were found in the 12-month stability samples.
Lots and codes
Lot# 605957A, Exp 09/14
Recall details
- Recalling firm
- Watson Laboratories, Inc.-(Actavis) - Florida, Davie, FL
- Quantity
- 5987 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 20, 2013
- Terminated
- September 17, 2014
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.