Drug product
fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0202-22, Bar code 70004020022,
D-0403-2024
Product summary
- Event
- Event 93456
- Status
- Terminated
- Classification
- Class II
- Quantity
- 500 syringes
- Official record key
drug-enforcement:D-0403-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 1223048959, Exp 12/11/23; 1223049009, Exp 12/12/23; 1223049170, Exp 12/20/23; 1223049245, Exp 12/22/23
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility