Drug recall D-1376-2015

Class III Terminated reported Sep 2, 2015

Product

Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-319-30) and b) 90 Count Bottles (NDC: 43598-319-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India.

Reason for recall

Subpotent Drug: Subpotent atorvastatin.

Lots and codes

a) Lot #: C403577, Expiry: 10/2015; b) Lot #: C403577, Expiry: 10/2015.

Recall details

Recalling firm
Dr. Reddy's Laboratories, Inc., Princeton, NJ
Quantity
a) 14,640 and b) 624 Bottles
Distribution
U.S. Nationwide
Type
Voluntary: Firm initiated
Recall initiated
August 13, 2015
Terminated
December 15, 2016

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