FDA-Drug2014-10-08Class II

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0397-60, UPC 3 05910 39760 9.

Actavis Laboratories, FL, Inc.
Hazard

Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.

Sold states
Nationwide and Puerto Rico
Affected count
6,041 bottles
Manufactured in
4955 Orange Dr, N/A, Davie, FL, United States
Products
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0397-60, UPC 3 05910 39760 9.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1617-2014

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