FDA-Drug2014-02-19Class II

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.

Watson Laboratories, Inc.-(Actavis) - Florida
Hazard

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

Sold states
Nationwide
Affected count
5987 bottles
Manufactured in
4955 Orange Dr, N/A, Davie, FL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1082-2014

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