Drug product
HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx Only, a) 30 mL Plungerless Single Dose Syringe (barcode 70004030016) and b) 30 mL Single Dose Syringe (barcode 70004030018), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095
D-0195-2021
Product summary
- Event
- Event 86990
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,092 syringes
- Official record key
drug-enforcement:D-0195-2021
Official wording
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Code information: a) Lot # 1220023171, BUD 1/26/2021; 1220023282, BUD 2/1/2021; 1220023446, BUD 2/7/2021; 1220023532, BUD 2/8/2021; 1220023650, BUD 2/11/2021 & 1220023727, BUD 2/14/2021. b) Lot # 1220023241, BUD 1/25/2021; 1220023313, BUD 2/1/2021 & 1220023442, BUD 2/7/2021.
Distribution pattern: Product was distributed to hospitals nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility