Drug recall D-1135-2015

Class II Terminated reported Jun 24, 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

Lots and codes

100 count bottle - Lot #C307859, exp 09/2015; 500 count bottle - Lot #C307859 and Lot# C307812, exp 09/2015

Recall details

Recalling firm
Dr. Reddy's Laboratories, Inc., Princeton, NJ
Quantity
100 count 7479; 500 count - 2544
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
May 22, 2015
Terminated
April 24, 2017

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