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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 68

Recalled August 9, 2017 · FDA recall D-1042-2017 · Zydus Pharmaceuticals USA

Hazard
Failed Dissolution Specifications · FDA Class II
Units
115,122 HDPE bottles
Sold at
Nationwide

Description

Failed Dissolution Specifications

Product
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
Manufacturer(s)
Zydus Pharmaceuticals USA Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

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 68 | RecallWatchUSA