DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS recalled over manufacturing violations

Recall date

April 24, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

MAJOR PHARMACEUTICALS recalls DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by D…

Recall number

D-1583-2019

FDA classification

Class II

Brand / firm

MAJOR PHARMACEUTICALS

Sold / distributed

Nationwide in the USA

Why it was recalled

cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.