Reported Jan 17, 2018 · Terminated

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…

Pfizer Manufacturing Deutschland GmbH

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Pfizer Manufacturing Deutschland GmbH · Pfizer GmbH Arzneimittelwerk Godecke · Freiburg im Breisgau, N/A · N/A

Is this the product you have?

  • 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
Lot codes and dates

4 of 4 products

Products covered by this recall
#Product as published
1S55350 Exp. 20 APR 2018, S55378 Exp. 07 MAR 2018, S55386 Exp. 14 MAR 2018, S53284 Exp.14 FEB 2018, S53283 Exp. 10 FEB 2018
2S53287 Exp. 16 FEB 2018, S33417 Exp. 03 FEB 2018
3S33445 Exp. 17 FEB 2018, S33452 Exp. 24 FEB 2018
4S33397 Exp. 07 FEB 2018
Amount recalled
a)7387263 tablets; b)5877188 tablets; c)11755825 tablets; d) 5872816 tablets

Why it was recalled

Microbial Contamination of Non-Sterile Products

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated May 11, 2020 · Data as of Sep 19, 5:55 PM UTC

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