FDA recall D-1043-2017

Zydus Pharmaceuticals USA Inc · Class II · drug

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

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2017-05-10
Report date: 2017-08-09
Termination date: 2020-01-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1043-2017