Drug product
fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0222-30 BAR code 70004022230
D-0396-2024
Product summary
- Event
- Event 93456
- Status
- Terminated
- Classification
- Class II
- Quantity
- 500 bags
- Official record key
drug-enforcement:D-0396-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 1223048351, Exp 11/30/23; 1223048532, Exp 12/07/23
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility