Recall: D-0258-2015

Class II - Potentially Harmful

Class IIClassification

2014-09-26Initiated

TerminatedStatus

Actavis Laboratories, FL, Inc.Firm

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: Presence of split or broken tablets.

Distribution

U.S. Nationwide including Puerto Rico.

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