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

Recall Number: D-0445-2023

Firm: Denver Solutions, LLC DBA Leiters Health

Classification: Class II

Status: Terminated

Report Date: 20230315

Initiation Date: 20230221

Termination Date: 20240111

CGMP DEVIATIONS

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