Drug product
Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09.
D-1843-2019
Product summary
- Event
- Event 83580
- Status
- Terminated
- Classification
- Class II
- Quantity
- 922 syringes
- Official record key
drug-enforcement:D-1843-2019
Official wording
Reason: Lack of Assurance of Sterility.
Code information: Lot #: 1219010961, Exp. 10/24/2019
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility