Drug product
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride (80 mcg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081612
D-0205-2021
Product summary
- Event
- Event 86990
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,890 syringes
- Official record key
drug-enforcement:D-0205-2021
Official wording
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Code information: Lot # 1220023039, BUD 1/21/2021; 1220023080, BUD 1/24/2021; 1220023374, BUD 2/3/2021; 1220023375, BUD 2/2/2021; 1220023490, BUD 2/7/2021; 1220023554, BUD 2/8/2021 & 1220023837, BUD 2/14/2021.
Distribution pattern: Product was distributed to hospitals nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility