Zydus Pharmaceuticals USA Inc recalls Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (ND
Recalled August 9, 2017 · FDA recall D-1043-2017 · Zydus Pharmaceuticals USA
Hazard
Failed Dissolution Specifications · FDA Class II
Units
108,726 HDPE bottles
Sold at
Nationwide
Description
Failed Dissolution Specifications
Product
Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054
Manufacturer(s)
Zydus Pharmaceuticals USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →