Recall: D-1082-2014

Class II - Potentially Harmful

Class IIClassification

2013-12-20Initiated

TerminatedStatus

Watson Laboratories, Inc.-(ActFirm

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.

Reason

Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.