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-0258-2015
Product summary
- Event
- Event 69495
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,451 Bottles
- Official record key
drug-enforcement:D-0258-2015
Official wording
Reason: Failed Tablet/Capsule Specifications: Presence of split or broken tablets.
Code information: Lot # 694320A, Expiry: 02/28/2015.
Distribution pattern: U.S. Nationwide including Puerto Rico.
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: Presence of split or broken tablets.