Recall: D-1135-2015

Class II - Potentially Harmful

Class IIClassification

2015-05-22Initiated

TerminatedStatus

Dr. Reddy's Laboratories, Inc.Firm

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

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

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.