FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk…

Date

Jan. 17, 2018

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

Pfizer Manufacturing Deutschland GmbH

Product

FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk, b) 40 mg SMT G EP PR KR, c) 20 mg SMT G EP PR, d) 20 mg SMT G EP PR KR, FOR MANUFACTURING, PROCESSING OR REPACKAGING

Reason

Microbial Contamination of Non-Sterile Products

Distribution pattern

Germany; products were packaged at the Pfizer Manufacturing Deutshland Gmbh location and then distributed to other countries. No product distributed in the United States or its territories.

Quantity

a)7387263 tablets; b)5877188 tablets; c)11755825 tablets; d) 5872816 tablets

Codes and lots

Bulk Product Batch # ( Packaged Lot#) a) S55350 Exp. 20 APR 2018, S55378 Exp. 07 MAR 2018, S55386 Exp. 14 MAR 2018, S53284 Exp.14 FEB 2018, S53283 Exp. 10 FEB 2018; b) S53287 Exp. 16 FEB 2018, S33417 Exp. 03 FEB 2018; c) S33445 Exp. 17 FEB 2018, S33452 Exp. 24 FEB 2018; d) S33397 Exp. 07 FEB 2018

Recall started

Sept. 27, 2017

Recall number

D-0212-2018

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0212-2018. The agency record governs; check it and the company before acting.