Drug recall D-1381-2014

Class II Terminated reported Jun 18, 2014

Product

Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories Limited, Batchupally - 500 090 India. NDC55111-466-01

Reason for recall

Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.

Lots and codes

Lot # C206578 Exp. 05/2014 Lot # C207415 Exp. 06/2014

Recall details

Recalling firm
Dr. Reddy's Laboratories, Inc., Princeton, NJ
Quantity
13560 bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
May 23, 2014
Terminated
May 1, 2015

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