Reported Jan 22, 2014 · Terminated
PEGASPARGASE ONCASPAR Injection, 3750 International Units Per 5mL vial, Rx ONLY, sigma-tau PHARMACEUTICALS INC, 9841…
Sigma-Tau Pharmaceuticals, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sigma-Tau Pharmaceuticals, Inc. · 9841 Washingtonian Blvd Ste 500 · Gaithersburg, MD · 20878-1978
Is this the product you have?
- 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
- Lot codes and dates
Lot# 3012A3013A30138Exp. 11/13 Lot# 3014A3014A CLINExp. 12/13
- Amount recalled
- 7479 vials
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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