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Denver Solutions, LLC DBA Leiters Health recalls Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compa

Recalled March 15, 2023 · FDA recall D-0444-2023 · Denver Solutions, LLC

Hazard
CGMP DEVIATIONS · FDA Class II
Units
1212 units
Sold at
Nationwide within the United States including VA or other Government facilities

Description

CGMP DEVIATIONS

Product
Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82
Manufacturer(s)
Denver Solutions, LLC DBA Leiters Health

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Denver Solutions, LLC DBA Leiters Health recalls Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compa | RecallWatchUSA