FDAFDA · Food and drugs·Recall number D-0373-2025
Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11
Published April 30, 2025 · Recall initiated: March 31, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Leaking/damaged syringes.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Distributor
- Nationwide in the U.S.A
- Lot
- Lot #:2530019, Exp.: 7/10/2025; 2530053, Exp.: 7/19/2025.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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