Recalls / Class II
Class IID-0370-2025
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
- Affected lot / code info
- Lot #: 2431015B, Exp. 4/10/2025.
Why it was recalled
Lack of Assurance of Sterility: Leaking/damaged syringes.
Recalling firm
- Firm
- Denver Solutions, LLC DBA Leiters Health
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 13796 Compark Blvd, N/A, Englewood, Colorado 80112-7145
Distribution
- Quantity
- 170 syringes
- Distribution pattern
- Nationwide in the U.S.A
Timeline
- Recall initiated
- 2025-03-31
- FDA classified
- 2025-04-18
- Posted by FDA
- 2025-04-30
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0370-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.