FDA recall D-0051-2020

KRS Global Biotechnology, Inc · Class II · drug

Product

fentaNYL Citrate in 0.9% Sodium Chloride (PF) 2,500 mcg/100 mL (25 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487 NDC 33216286000

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-0051-2020