FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT… — Class II drug recall D-0212-2018
Terminated recall by Pfizer Manufacturing Deutschland GmbH, reported 2018-01-17. Microbial Contamination of Non-Sterile Products
| Recall number | D-0212-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Manufacturing Deutschland GmbH, Freiburg im Breisgau, N/A, Germany |
| Recall initiated | 2017-09-27 |
| Classified | 2018-01-08 |
| Reported by FDA | 2018-01-17 |
| Terminated | 2020-05-11 |
| Countries outside the US | DE |
| Reason classes | microbial contamination, sterility |
| Lot numbers | S33397, S33417, S33445, S33452, S53283, S53284, S53287, S55350, S55378, S55386 |
| Expiration dates | 2018-02-03, 2018-02-07, 2018-02-10, 2018-02-14, 2018-02-16, 2018-02-17, 2018-02-24, 2018-03-07, 2018-03-14, 2018-04-20 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0212-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.