FDA recall D-0045-2020
KRS Global Biotechnology, Inc · Class II · drug
Product
L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL (75 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676396
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-0045-2020