D-0419-2024 Class II Terminated
FDA drug recall D-0419-2024 was initiated by SCA Pharmaceuticals, LLC on November 9, 2023 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated August 27, 2024). Affected quantity: 400 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- April 3, 2024
- Initiation Date
- November 9, 2023
- Termination Date
- August 27, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 400 bags
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 1223050005 Exp 01/13/24