Class IIReported 2025-04-30

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

Recalled by Denver Solutions, LLC DBA Leiters Health

Reason for Recall

Lack of Assurance of Sterility: Leaking/damaged syringes.

Recall Number

D-0373-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-03-31

Reported

2025-04-30

Distribution

Nationwide in the U.S.A

Code Info

Lot #:2530019, Exp.: 7/10/2025; 2530053, Exp.: 7/19/2025.

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.