Reported Feb 2, 2022 · Terminated
PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for IV injection…
Edge Pharma, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edge Pharma, LLC · 856 Hercules Dr · Colchester, VT · 05446-8014
Is this the product you have?
- 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
- Lot codes and dates
- 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.
- Amount recalled
- 3930 bags
This recall covers 56 products
The agency filed one notice per product. You are reading one of them; the other 55 are below.
43 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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