Recall: D-0507-2019

Class II - Potentially Harmful

Class IIClassification

2019-01-31Initiated

TerminatedStatus

Dr. Reddy's Laboratories, Inc.Firm

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

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

Distribution

U.S.A. 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.