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

FDA recall notice · announced January 17, 2018 · Pfizer Manufacturing Deutschland

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

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.
Lot/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
Quantity: a)7387263 tablets; b)5877188 tablets; c)11755825 tablets; d) 5872816 tablets
Status: Terminated
Products in this recall event:
- 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 (D-0212-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.