Zydus Pharmaceuticals USA Inc recalls Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC 6…

Recall date

May 10, 2017

Source

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

Recall number

D-1042-2017

FDA classification

Class II

Brand / firm

Zydus Pharmaceuticals USA Inc

Sold / distributed

Nationwide

Why it was recalled

Failed Dissolution Specifications

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 Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC 68382-032-05),Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054