FDAFDA · Food and drugs·Recall number D-0205-2021
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride (80 mcg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081612
Published January 13, 2021 · Recall initiated: December 17, 2020
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; potential for a defective syringe cap, resulting in a non-integral unit
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SCA Pharmaceuticals
- Distributor
- Product was distributed to hospitals nationwide.
- Lot
- Lot # 1220023039, BUD 1/21/2021; 1220023080, BUD 1/24/2021; 1220023374, BUD 2/3/2021; 1220023375, BUD 2/2/2021; 1220023490, BUD 2/7/2021; 1220023554, BUD 2/8/2021 & 1220023837, BUD 2/14/2021.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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