Class II
Terminated
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.
This recall has been terminated (originally issued February 19, 2014).
- Recall Initiated
- December 20, 2013
- Posted
- February 19, 2014
- Recall Number
- D-1082-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 5987 bottles
- Firm Location
- Davie, FL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.
Distribution
Nationwide
Lot / Code Info
Lot# 605957A, Exp 09/14
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