← FDA ENFORCEMENT
D-0370-2025Class II

Denver Solutions, LLC DBA Leiters Health

Recalling firm
Denver Solutions, LLC DBA Leiters Health
Product type
Drug
Status
Ongoing
Report date
2025-04-30
Distribution
Nationwide in the U.S.A
Firm state
CO
Product quantity
170 syringes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility: Leaking/damaged syringes.

Product description

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

Code / lot info

Lot #: 2431015B, Exp. 4/10/2025.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.