Zydus Pharmaceuticals USA Inc recalls Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033…

Recall date

March 15, 2017

Source

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

Recall number

D-0617-2017

FDA classification

Class II

Brand / firm

Zydus Pharmaceuticals USA Inc

Sold / distributed

Nationwide

Why it was recalled

Failed Dissolution Specifications; 9 month long term stability

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, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ