Drug product
Ketamine in 0.9% Sodium Chloride (PF) 50 mg/ 5mL (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 3321678093
D-0065-2020
Product summary
- Event
- Event 83789
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11733 syringes
- Official record key
drug-enforcement:D-0065-2020
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