Recall: D-1136-2015
Class II - Potentially Harmful
Class IIClassification
2015-05-22Initiated
TerminatedStatus
Dr. Reddy's Laboratories, Inc.Firm
Product
Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited Bachupally 500 090 India --- NDC 55111-534-01
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.