FDAHealthMarch 31, 2025
Denver Solutions, LLC DBA Leiters Health — 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
⚠️ 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
- 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,
- Lot code
- 2431349A
Additional details
Lot #: 2431349A, Exp.: 6/16/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 7,290 syringes.
Get Health recall alerts
Delivered to your inbox. Free. No account required.