D-0212-2018 Class II Terminated
FDA drug recall D-0212-2018 was initiated by Pfizer Manufacturing Deutschland GmbH on Sep 27, 2017 and is designated Class II. Reason for recall: Microbial Contamination of Non-Sterile Products The recall status is terminated (terminated May 11, 2020). Affected quantity: a)7387263 tablets; b)5877188 tablets; c)11755825 tablets; d) 5872816 tablets.
Recall details
- Product Type
- Drugs
- Report Date
- Jan 17, 2018
- Initiation Date
- Sep 27, 2017
- Termination Date
- May 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a)7387263 tablets; b)5877188 tablets; c)11755825 tablets; d) 5872816 tablets
Product description
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 pattern
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.
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0212-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026