FDAHealthMarch 31, 2025
Denver Solutions, LLC DBA Leiters Health — 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
⚠️ Lack of Assurance of Sterility: Leaking/damaged syringes.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 31, 2025
Nationwide in the U.S.A
What's affected?
- Product
- 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
- Lot code
- 2431015B
Additional details
Lot #: 2431015B, Exp. 4/10/2025.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 170 syringes.
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