Denver Solutions, LLC DBA Leiters Health 2024-02-07 Health critical FDA
Health · FDA · Recall #FDA-D-0279-2024
PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for… Recall
Issued February 7, 2024 · Denver Solutions, LLC DBA Leiters Health
In February 2024, Denver Solutions, LLC DBA Leiters Health recalled the PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
What you should do
- 1 Stop using PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Denver Solutions, LLC DBA Leiters Health to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Denver Solutions, LLC DBA Leiters Health
- Category
- Health
- Recall date
- February 7, 2024
- Units affected
- Not reported
- Sold at
- Nationwide within the United States
- Recall number
- FDA-D-0279-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Denver Solutions, LLC DBA Leiters Health has 12 recalls in our database, including 6 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.