Drug product
fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, 877.550.5059, NDC 70004-0229-40 BAR code 70004022940
D-0395-2024
Product summary
- Event
- Event 93456
- Status
- Terminated
- Classification
- Class II
- Quantity
- 548 bags
- Official record key
drug-enforcement:D-0395-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 1223045757, Exp 12/27/23; 1223049716, Exp 5/25/24
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility