Drug product
fentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004020016
D-0193-2021
Product summary
- Event
- Event 86990
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,834 syringes
- Official record key
drug-enforcement:D-0193-2021
Official wording
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Code information: Lot # 1220022977, BUD 1/20/2021; 1220023122, BUD 1/25/2021; 1220023209, BUD 1/28/2021; 1220023248, BUD 1/27/2021; 1220023319, BUD 2/1/2021; 1220023496, BUD 2/8/2021 & 1220023560, BUD 2/9/2021.
Distribution pattern: Product was distributed to hospitals nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility