FDA recall D-0053-2020
KRS Global Biotechnology, Inc · Class II · drug
Product
Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321674186
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-0053-2020