Atorvastatin Calcium Tablets…

Date

March 25, 2020

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Sun Pharmaceutical Industries, Inc.

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

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

Distribution pattern

U.S.A. Nationwide

Quantity

1416 bottles

Codes and lots

Lot#: AA33617, Exp 03/2021

Recall started

March 9, 2020

Recall number

D-1047-2020

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-1047-2020. The agency record governs; check it and the company before acting.