Drug recall D-1377-2015

Class III Terminated reported Sep 2, 2015

Product

Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-318-30) and b) 90 Count Bottles (NDC: 43598-318-90), 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 #: C404592, Expiry: 11/2015. b) Lot #: C404592, Expiry: 11/2015

Recall details

Recalling firm
Dr. Reddy's Laboratories, Inc., Princeton, NJ
Quantity
a) 16,080 and b) 480 Bottles
Distribution
U.S. Nationwide
Type
Voluntary: Firm initiated
Recall initiated
August 13, 2015
Terminated
December 15, 2016

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