Drug recall D-1136-2015

Class II Terminated reported Jun 24, 2015

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 for recall

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

Lots and codes

Lot #C308195, exp 10/2015

Recall details

Recalling firm
Dr. Reddy's Laboratories, Inc., Princeton, NJ
Quantity
5,160 bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
May 22, 2015
Terminated
April 24, 2017

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