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-1082-2014
Product summary
- Event
- Event 67259
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5987 bottles
- Official record key
drug-enforcement:D-1082-2014
Official wording
Reason: Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.
Code information: Lot# 605957A, Exp 09/14
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.