Denver Solutions, LLC DBA Leiters Health recalls Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 137
Recalled March 15, 2023 · FDA recall D-0445-2023 · Denver Solutions, LLC
Hazard
CGMP DEVIATIONS · FDA Class II
Units
8,136 units
Sold at
Nationwide within the United States including VA or other Government facilities
Description
CGMP DEVIATIONS
Product
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
Manufacturer(s)
Denver Solutions, LLC DBA Leiters Health
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →