FDA recall D-0083-2020

KRS Global Biotechnology, Inc · Class II · drug

Product

OxyTOCIN in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL (0.06 Units / mL) Single Dose IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676819

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-0083-2020