FDA recall D-0507-2019

Dr. Reddy's Laboratories, Inc. · Class II · drug

Product

Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India NDC 55111-533-01

Reason for recall

Failed Dissolution Specifications: Out of specification results observed for high dissolution.

Distribution

U.S.A. Nationwide

Key facts

Status: Terminated
Initiation date: 2019-01-31
Report date: 2019-02-27
Termination date: 2023-02-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0507-2019