Home / Recalls / Pfizer Manufacturing Deutschland GmbH / D-0212-2018

D-0212-2018 Class II Terminated

Recalled by Pfizer Manufacturing Deutschland GmbH — Freiburg im Breisgau, N/A

Recall Details

Product Type: Drugs
Report Date: January 17, 2018
Initiation Date: September 27, 2017
Termination Date: May 11, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: a)7387263 tablets; b)5877188 tablets; c)11755825 tablets; d) 5872816 tablets

Product Description

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 for Recall

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.

Code Information

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