# FDA recall D-0995-2020

> **Pfizer Inc.** · Class II · drug recall initiated 2020-02-27.

## Product

Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017.  NDC 0069-0106-01

## Reason for recall

Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.

## Distribution

Nationwide within the United States and Albania, Israel, Serbia, Macedonia, Afghanistan, Botswana/South Africa/Zimbabwe, India, Israel, Rwanda, Uruguay, Mongolia

## Key facts

- **Recall number:** D-0995-2020
- **Recalling firm:** Pfizer Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-02-27
- **Report date:** 2020-03-11
- **Termination date:** 2022-12-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New York, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0995-2020

## Citation

> AI Analytics. FDA recall D-0995-2020. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0995-2020. Source: US FDA. Licensed CC0.

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