Drug product
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 (60 count bottles)
D-1060-2014
Product summary
- Firm
- Actavis Inc
- Event
- Event 66380
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,540 bottles
- Official record key
drug-enforcement:D-1060-2014
Official wording
Reason: Failed Tablet/Capsule Specifications: Broken tablets
Code information: Lot 668271A, Exp 11/14 and Lot 684119A Exp 01/2015
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: Broken tablets