FDA Recall D-0373-2025
Denver Solutions, LLC DBA Leiters Health · Englewood, CO
Class II Ongoing 409 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
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
Reason for recall
Lack of Assurance of Sterility: Leaking/damaged syringes.
Recall record
- Recall number
D-0373-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the U.S.A
- Recall initiated
- 2025-03-31
- Classified by FDA Center
- 2025-04-18
- FDA published
- 2025-04-30
- Recalling firm
- Denver Solutions, LLC DBA Leiters Health
- Firm location
- Englewood, CO
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.