FDA recall D-0212-2018

Pfizer Manufacturing Deutschland GmbH · Class II · drug

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 for recall

Microbial Contamination of Non-Sterile Products

Distribution

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.

Key facts

Status: Terminated
Initiation date: 2017-09-27
Report date: 2018-01-17
Termination date: 2020-05-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Freiburg im Breisgau, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0212-2018