D-1082-2014 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 19, 2014
- Initiation Date
- December 20, 2013
- Termination Date
- September 17, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5987 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: Split tablets were found in the 12-month stability samples.
Distribution Pattern
Nationwide
Code Information
Lot# 605957A, Exp 09/14