Reported Mar 15, 2023 · Terminated
Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health…
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?
- Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94
- Lot codes and dates
Lot #: 2231026Exp. Date 2/23/20232231051Exp. Date 3/11/20232231156Exp. Date 5/29/20232231163Exp. Date 3/26/2023223130Exp. Date 4 5/7/20232231308Exp. Date 5/11/2023
- Amount recalled
- 8,136 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- VA
Why it was recalled
CGMP DEVIATIONS
This product could cause temporary or reversible health problems — stop using it.
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