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
Recall Number: D-0444-2023
Firm: Denver Solutions, LLC DBA Leiters Health
Classification: Class II
Status: Terminated
Report Date: 20230315
Initiation Date: 20230221
Termination Date: 20240111
Reason for Recall
CGMP DEVIATIONS
Product Description
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