FDAFDA · Food and drugs·Recall number D-0415-2024
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11, Bar Code 70004081011
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 #: 1223045053 Exp 11/15/23; 1223046179 Exp 12/28/23; 1223047477 Exp 02/16/24; 1223047602 Exp 02/22/24; 1223047971 Exp 03/14/24; 1223048269 Exp 03/27/24 Expanded lot#: 1223048181, exp. date 03/22/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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