Drug product
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60
D-817-2013
Product summary
- Event
- Event 65541
- Status
- Terminated
- Classification
- Class II
- Quantity
- 392,400 tablets
- Official record key
drug-enforcement:D-817-2013
Official wording
Reason: Failed Tablet/Capsule Specifications: Broken tablets
Code information: Lot 635098A, Exp 10/14
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: Broken tablets