Drug 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
D-0370-2025
Product summary
- Event
- Event 96607
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 170 syringes
- Official record key
drug-enforcement:D-0370-2025
Official wording
Reason: Lack of Assurance of Sterility: Leaking/damaged syringes.
Code information: Lot #: 2431015B, Exp. 4/10/2025.
Distribution pattern: Nationwide in the U.S.A
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility