Reported Feb 7, 2024 · Ongoing
PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796…
Denver Solutions, LLC dba Leiters Health
High riskUsing this product could cause serious injury, illness or death — stop using it now.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: Denver Solutions, LLC DBA Leiters Health · 13796 Compark Blvd · Englewood, CO · 80112-7145
Is this the product you have?
- PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94.
- Lot codes and dates
Lot #: 2330993Exp. Date 02/15/20242331010Exp. Date 02/10/20242331055Exp. Date 01/18/20242331113Exp. Date 02/26/20242331181Exp. Date 03/04/20242331187Exp. Date 03/23/20242331266Exp. Date 03/31/20242331343Exp. Date 04/01/20242331349Exp. Date 04/23/20242331433Exp. Date 05/05/2024
- Amount recalled
- 29,016 IV bags
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Using this product could cause serious injury, illness or death — stop using it now.
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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