Reported Mar 6, 2024 · Ongoing
Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796…
Denver Solutions, LLC dba Leiters Health
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: Denver Solutions, LLC DBA Leiters Health · 13796 Compark Blvd · Englewood, CO · 80112-7145
Is this the product you have?
Lidocaine HCL 1% (10mg/mL)PHENYLephrine HCL 1.5% (15mg/mL)1 ml in a Single- Dose VialRX OnlyLeiters 13796 Compark BlvdEnglewoodCO 80112NDC 71449-090-42
- Lot codes and dates
- Lot #:2331104
- Exp
9-Mar-242331137
- Exp
3-Mar-242331196
- Exp
11-Mar-242331264
- Exp
6-Apr-242331282
- Exp
18-Apr-242331464
- Exp
8-May-242331481
- Exp
16-May-242331500
- Exp20-May-24
- Amount recalled
- 40,890 vials
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
This product could cause temporary or reversible health problems — stop using it.
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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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