FDA-Drug2023-03-15Class II
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
Denver Solutions, LLC DBA Leiters Health
Hazard
CGMP DEVIATIONS
Sold states
Nationwide within the United States including VA or other Government facilities
Affected count
8,136 units
Manufactured in
13796 Compark Blvd, Englewood, CO, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0445-2023Don't want to check this manually?
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