FDAFDA · Food and drugs·Recall number D-0418-2022
PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for IV injection (Preservative Free), Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT NDC 05446-1667-01
Published February 2, 2022 · Recall initiated: December 6, 2021
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 · Press Release
Recall details
- Manufacturer
- Edge Pharma, LLC
- Distributor
- nationwide
- Lot
- 08-2021-24@6 12/06/2021, 08-2021-31@7 12/12/2021, 09-2021-07@3 12/21/2021, 10-2021-20@2 02/02/2022 & 10-2021-28@2 02/10/2022.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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