Dr. Reddy's Laboratories, Inc. recalls Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (ND
Recalled April 24, 2019 · FDA recall D-1133-2019 · Dr. Reddy's Laboratories
Hazard
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations. · FDA Class II
Units
33,958 bottles
Sold at
Product was distributed to major distributors and retailers who may have further distribute the product throughout the United States.
Description
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Product
Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), 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 →