Drug product
Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674177
D-0042-2020
Product summary
- Event
- Event 83789
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6568 vials
- Official record key
drug-enforcement:D-0042-2020
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