FDA recall D-0617-2017

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

Reason for recall

Failed Dissolution Specifications; 9 month long term stability

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-03-15

Report date

2017-04-05

Termination date

2020-09-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0617-2017