Divalproex Sodium Extended-Release Tablets recalled over manufacturing violations

Recall date

April 11, 2019

Source

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

Official notice title

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 (N…

Recall number

D-1133-2019

FDA classification

Class II

Brand / firm

Dr. Reddy's Laboratories, Inc.

Sold / distributed

Product was distributed to major distributors and retailers who may have further distribute the product throughout the United States.

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, 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