FDA recall D-0117-2020

KRS Global Biotechnology, Inc · Class II · drug

Product

L-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674499

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2019-09-12
Report date
2019-10-09
Termination date
2021-08-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Boca Raton, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0117-2020