FDA recall D-0115-2020

KRS Global Biotechnology, Inc · Class II · drug

Product

Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678335

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-0115-2020