FDA recall D-1135-2015

Product

Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India

Reason for recall

Failed Dissolution Specifications; exceeded specification at the 9 hour time point

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-05-22

Report date

2015-06-24

Termination date

2017-04-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1135-2015