Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PEGASPARGASE ONCASPAR Injection Recalled by Sigma-Tau Pharmaceuticals, Inc. Due to Lack of Assurance of Sterility: Sigma-Tau PharmaSource, Inc....
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sigma-Tau Pharmaceuticals, Inc. directly.
Affected 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
Quantity: 7479 vials
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sigma-Tau Pharmaceuticals, Inc.
Sigma-Tau Pharmaceuticals, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report