FDA recall D-0063-2020
KRS Global Biotechnology, Inc · Class II · drug
Product
Hydroxocobalamin 30 mg/30 mL (1 mg/mL) 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678334
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-0063-2020