Drug product
fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004020006
D-0214-2021
Product summary
- Event
- Event 86990
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6710 syringes
- Official record key
drug-enforcement:D-0214-2021
Official wording
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Code information: Lot #1220023109, BUD 1/25/2021; 1220023255, BUD 1/26/2021; 1220023256. BUD 1/26/2021; 1220023257, BUD 1/28/2021; 1220023334, BUD 2/2/2021 & 1220023518, BUD 2/8/2021.
Distribution pattern: Product was distributed to hospitals nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility