Drug recall D-0258-2015
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: Presence of split or broken tablets.
Lots and codes
Lot # 694320A, Expiry: 02/28/2015.
Recall details
- Recalling firm
- Actavis Laboratories, FL, Inc., Davie, FL
- Quantity
- 5,451 Bottles
- Distribution
- U.S. Nationwide including Puerto Rico.
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 26, 2014
- Terminated
- June 16, 2015
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.