FDAFDA · Food and drugs·Recall number D-0416-2024
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-K, Bar Code 70004081011. (same finished product as F078140, but with RFID for KitCheck
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 #: 1223048431 exp 04/05/24; 1223049023 exp 04/25/24
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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