FDA Drug Class II — Moderate

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

Hazard

CGMP DEVIATIONS

Products

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
Brand
Denver Solutions, LLC DBA Leiters Health
UPC
Lot #: 2230960, Exp date 3/12/2023; 2231080, Exp date 4/9/2023.

Units Affected

13,445 units