FDA recall D-736-2014

Sigma-Tau Pharmaceuticals, Inc. · Class II · drug

Product

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

Reason for recall

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.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-11-01
Report date: 2014-01-22
Termination date: 2014-12-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Gaithersburg, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-736-2014