Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11

Recall Number: D-0442-2023

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 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11