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
Recalled April 5, 2017 · FDA recall D-0617-2017 · Zydus Pharmaceuticals USA
Hazard
Failed Dissolution Specifications; 9 month long term stability · FDA Class II
Units
32628 bottles
Sold at
Nationwide
Description
Failed Dissolution Specifications; 9 month long term stability
Product
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
Manufacturer(s)
Zydus Pharmaceuticals USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →