Drug recall D-1378-2015

Class III Terminated reported Sep 2, 2015

Product

Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-315-30) and b) 90 Count Bottles (NDC: 43598-315-90), 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 #: C409650, Expiry: 05/2016; Lot #: C409652,Expiry: 05/2016. b) Lot #: C409652, Expiry: 05/2016

Recall details

Recalling firm
Dr. Reddy's Laboratories, Inc., Princeton, NJ
Quantity
a) 16,848 and b) 216 Bottles
Distribution
U.S. Nationwide
Type
Voluntary: Firm initiated
Recall initiated
August 13, 2015
Terminated
December 15, 2016

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