Pfizer Manufacturing Deutschland product recalled over sterility concerns

Recall date

September 27, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Pfizer Manufacturing Deutschland GmbH recalls 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…

Recall number

D-0212-2018

FDA classification

Class II

Brand / firm

Pfizer Manufacturing Deutschland GmbH

Sold / distributed

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.

Why it was recalled

Microbial Contamination of Non-Sterile Products

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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