FDA-Drug2018-01-17Class II

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

Pfizer Manufacturing Deutschland GmbH
Hazard

Microbial Contamination of Non-Sterile Products

Sold states
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.
Affected count
a)7387263 tablets; b)5877188 tablets; c)11755825 tablets; d) 5872816 tablets
Manufactured in
Pfizer GmbH Arzneimittelwerk Godecke, (Betriebsstatte Freiburg), Freiburg im Breisgau, N/A, Germany
Products
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

Official notice

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

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