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
Reported: April 30, 2025 Initiated: March 31, 2025 #D-0373-2025
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.
Details
- Recalling Firm
- Denver Solutions, LLC DBA Leiters Health
- Units Affected
- 49,830 syringes
- Distribution
- Nationwide in the U.S.A
- Location
- Englewood, CO
Frequently Asked Questions
What product was recalled? ▼
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. Units affected: 49,830 syringes.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Leaking/damaged syringes.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 30, 2025. Severity: Moderate. Recall number: D-0373-2025.
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