Drug product
Magnesium Chloride Hexahydrate 82.5 mg/mL; Calcium Gluconate 30 mg/mL (PF), For IV Use, 10 mL Single Dose vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678355
D-0074-2020
Product summary
- Event
- Event 83789
- Status
- Terminated
- Classification
- Class II
- Quantity
- 878 vials
- Official record key
drug-enforcement:D-0074-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: All lots remaining within expiry.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility