MAJOR PHARMACEUTICALS recalls DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr
Recalled August 7, 2019 · FDA recall D-1583-2019 · MAJOR PHARMACEUTICALS
Hazard
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations. · FDA Class II
Units
828 100-count unit dose cartons
Sold at
Nationwide in the USA
Description
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Product
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.
Manufacturer(s)
MAJOR PHARMACEUTICALS
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →