# FDA recall D-736-2014

> **Sigma-Tau Pharmaceuticals, Inc.** · Class II · drug recall initiated 2013-11-01.

## Product

PEGASPARGASE ONCASPAR Injection, 3750 International Units Per 5mL vial, Rx ONLY, sigma-tau PHARMACEUTICALS INC, 9841 Washingtonian Blvd, Gaithersburg, MD 20878 NDC 54482-301-01

## Reason for recall

Lack of Assurance of Sterility: Sigma-Tau PharmaSource, Inc. is conducting a voluntary recall of five lots of Oncaspar Injection, because of a crack under the crimp seal which caused a leak.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-736-2014
- **Recalling firm:** Sigma-Tau Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-11-01
- **Report date:** 2014-01-22
- **Termination date:** 2014-12-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gaithersburg, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-736-2014

## Citation

> AI Analytics. FDA recall D-736-2014. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-736-2014. Source: US FDA. Licensed CC0.

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