Drug product
PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0825-40, Bar Code 70004082540.
D-0419-2024
Product summary
- Event
- Event 93456
- Status
- Terminated
- Classification
- Class II
- Quantity
- 400 bags
- Official record key
drug-enforcement:D-0419-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 1223050005 Exp 01/13/24
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility