FDA-Drug2025-04-30Class II

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

Denver Solutions, LLC DBA Leiters Health
Hazard

Lack of Assurance of Sterility: Leaking/damaged syringes.

Sold states
Nationwide in the U.S.A
Affected count
170 syringes
Manufactured in
13796 Compark Blvd, N/A, Englewood, CO, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0370-2025

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