D-817-2013 Class II Terminated
FDA drug recall D-817-2013 was initiated by Watson Laboratories, Inc.-(Actavis) - Florida on March 22, 2013 and is designated Class II. Reason for recall: Failed Tablet/Capsule Specifications: Broken tablets The recall status is terminated (terminated September 25, 2014). Affected quantity: 392,400 tablets.
Recall Details
- Product Type
- Drugs
- Report Date
- July 31, 2013
- Initiation Date
- March 22, 2013
- Termination Date
- September 25, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 392,400 tablets
Product Description
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
Reason for Recall
Failed Tablet/Capsule Specifications: Broken tablets
Distribution Pattern
Nationwide
Code Information
Lot 635098A, Exp 10/14