Drug product
PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,
D-0372-2025
Product summary
- Event
- Event 96607
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7,290 syringes
- Official record key
drug-enforcement:D-0372-2025
Official wording
Reason: Lack of Assurance of Sterility: Leaking/damaged syringes.
Code information: Lot #: 2431349A, Exp.: 6/16/2025
Distribution pattern: Nationwide in the U.S.A
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility