Status
Ongoing
Drug Enforcement D-0372-2025
Lack of Assurance of Sterility: Leaking/damaged syringes.
Classification
Class II
Report Date
April 30, 2025
Termination Date
—
Product Information
- Product description
- 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,
- Product quantity
- 7,290 syringes
- Reason for recall
- Lack of Assurance of Sterility: Leaking/damaged syringes.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the U.S.A
Location & Firm
- Recalling firm
- Denver Solutions, LLC DBA Leiters Health
- Address
-
13796 Compark Blvd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0372-2025
- Event ID
- 96607
- Recall initiation date
- March 31, 2025
- Center classification date
- April 18, 2025
- Code info
- Lot #: 2431349A, Exp.: 6/16/2025
- More code info
- —