Drug recall D-1047-2020

Class II Terminated reported Mar 25, 2020

Product

Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-829-05

Reason for recall

Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.

Lots and codes

Lot#: AA33617, Exp 03/2021

Recall details

Recalling firm
Sun Pharmaceutical Industries, Inc., Cranbury, NJ
Quantity
1416 bottles
Distribution
U.S.A. Nationwide
Type
Voluntary: Firm initiated
Recall initiated
March 9, 2020
Terminated
February 9, 2021

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