FDA-Drug2014-01-22Class II
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
Sigma-Tau Pharmaceuticals, Inc.
Hazard
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.
Sold states
Nationwide
Affected count
7479 vials
Manufactured in
9841 Washingtonian Blvd Ste 500, Gaithersburg, MD, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-736-2014Don't want to check this manually?
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