D-0258-2015 Class II Terminated
FDA drug recall D-0258-2015 was initiated by Actavis Laboratories, FL, Inc. on September 26, 2014 and is designated Class II. Reason for recall: Failed Tablet/Capsule Specifications: Presence of split or broken tablets. The recall status is terminated (terminated June 16, 2015). Affected quantity: 5,451 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 3, 2014
- Initiation Date
- September 26, 2014
- Termination Date
- June 16, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,451 Bottles
Product Description
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.
Distribution Pattern
U.S. Nationwide including Puerto Rico.
Code Information
Lot # 694320A, Expiry: 02/28/2015.