Drug product
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12, Bar Code 700040081612.
D-0420-2024
Product summary
- Event
- Event 93456
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,671 syringes, expanded 1,911 syringes
- Official record key
drug-enforcement:D-0420-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 1223045974 Exp 12/18/23; 1223046535 Exp 01/11/24; 1223049152 Exp 05/02/24 Expanded Lot #: 1223048067, Exp 04/06/2024; 1223048792, Exp 04/17/2024.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility