FDAFDA · Food and drugs·Recall number D-0216-2021
PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081022
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 # 1220023003, BUD 12/22/2020; 1220023057, BUD 12/25/2020; 1220023104, BUD 12/25/2020; 1220023144, BUD 12/27/2020; 1220023168, BUD 12/27/2020; 1220023222, BUD 12/29/2020; 1220023240, BUD 12/28/2020; 1220023284, BUD 1/1/2021; 1220023456, BUD 1/8/2021; 1220023474, BUD 1/4/2021; 1220023530, BUD 1/8/2021 & 1220023542, BUD 1/9/2021.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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