# FDA recall D-0212-2018

> **Pfizer Manufacturing Deutschland GmbH** · Class II · drug recall initiated 2017-09-27.

## 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

## 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.

## Key facts

- **Recall number:** D-0212-2018
- **Recalling firm:** Pfizer Manufacturing Deutschland GmbH
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-09-27
- **Report date:** 2018-01-17
- **Termination date:** 2020-05-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Freiburg im Breisgau, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0212-2018

## Citation

> AI Analytics. FDA recall D-0212-2018. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/D-0212-2018. Source: US FDA. Licensed CC0.

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