Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11

Recall Number: D-0370-2025

Firm: Denver Solutions, LLC DBA Leiters Health

Classification: Class II

Status: Ongoing

Report Date: 20250430

Initiation Date: 20250331

Termination Date:

Lack of Assurance of Sterility: Leaking/damaged syringes.

Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11