FDA recall D-0068-2020
KRS Global Biotechnology, Inc · Class II · drug
Product
LIDOcaine HCl 1% (PF) 50 mg/5 mL (10 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678424
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-0068-2020