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Dr. Reddy's Laboratories, Inc. recalls Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500

Recalled June 24, 2015 · FDA recall D-1135-2015 · Dr. Reddy's Laboratories

Hazard
Failed Dissolution Specifications; exceeded specification at the 9 hour time point · FDA Class II
Units
100 count 7479; 500 count - 2544
Sold at
Nationwide

Description

Failed Dissolution Specifications; exceeded specification at the 9 hour time point

Product
Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India
Manufacturer(s)
Dr. Reddy's Laboratories, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov