FDA recall D-0072-2020

KRS Global Biotechnology, Inc · Class II · drug

Product

Methionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxine HCl 1,500 mg / Cyanocobalamin 30 mg Lyophilized, Vial For IM Use, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321675952

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-0072-2020