Sigma-Tau Pharmaceuticals recalls

FDA enforcement reports naming Sigma-Tau Pharmaceuticals, Inc. as the recalling firm.

Recall reports: 1
Class I (serious): 0
Most recent report: Jan 22, 2014

Severity

Jan 22, 2014PEGASPARGASE ONCASPAR Injection, 3750 International Units Per 5mL vial, Rx ONLY, sigma-…Drug · Sigma-Tau Pharmaceuticals, Inc.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.Class II