PEGASPARGASE ONCASPAR Injection, 3750 International Units Per 5mL vial, Rx ONLY…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
What was recalled
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
- Recalling firm
- Sigma-Tau Pharmaceuticals, Inc.
- NDC code
- 54482-301-01
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-736-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.