# FDA recall D-0621-2017

> **Mylan Pharmaceuticals Inc.** · Class II · drug recall initiated 2017-03-20.

## Product

Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV  26505 U.S.A.

## Reason for recall

Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-0621-2017
- **Recalling firm:** Mylan Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-03-20
- **Report date:** 2017-04-05
- **Termination date:** 2018-01-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morgantown, WV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0621-2017

## Citation

> AI Analytics. FDA recall D-0621-2017. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0621-2017. Source: US FDA. Licensed CC0.

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