Reported Feb 7, 2024 · Ongoing
PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, 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 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-150-82.
- Lot codes and dates
Lot #: 2330939Exp. Date 01/30/20242331032Exp. Date 02/03/20242331112Exp. Date 03/19/20242331190Exp. Date 03/26/20242331429Exp. Date 04/28/2024
- Amount recalled
- 12,564 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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