D-0373-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- April 30, 2025
- Initiation Date
- March 31, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49,830 syringes
Product Description
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.
Distribution Pattern
Nationwide in the U.S.A
Code Information
Lot #:2530019, Exp.: 7/10/2025; 2530053, Exp.: 7/19/2025.