FDAFDA · Food and drugs·Recall number D-0420-2024
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.
Published April 3, 2024 · Recall initiated: November 9, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SCA Pharmaceuticals, LLC
- Distributor
- Nationwide in the USA
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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