FDA Drug Class II — Moderate

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

Hazard

Lack of Assurance of Sterility: Leaking/damaged syringes.

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Products

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
Brand
Denver Solutions, LLC DBA Leiters Health
UPC
Lot #:2530019, Exp.: 7/10/2025; 2530053, Exp.: 7/19/2025.

Units Affected

49,830 syringes

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