Class II · Moderate risk
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection
CGMP Deviations
dexmedeTOMIDine HCl PF
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Leaking/damaged syringes.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131-11.
Affected NDC
71449-0131-11
Compare with the code on your package — it is the most precise check available.
Drug: Dexmedetomidine
- Recalling firm
- Denver Solutions, LLC DBA Leiters Health
- Origin
- CO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0371-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Dexmedetomidine recalls
See all
Class II · Moderate risk
Dexmedetomidine HCL Single Dose Vial 200 mcg per 2 mL
cGMP deviations: Temperature abuse
Class I · High risk
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection
Cross Contamination with other products: trace amounts of lidocaine
Class I · High risk
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection
Cross Contamination with other products: trace amounts of lidocaine
Class II · Moderate risk
Dexmedetomidine 400 mcg in NS 100 mL bag
Lack of sterility assurance.
Other recalls by Denver Solutions, LLC DBA Leiters Health
All 2025 recalls
Class II · Moderate risk
Rocuronium Bromide 50 mg per 5mL
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk
Ketamine HCl 50mg per 5mL
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk
PHENYLephrine HCl in 0.9% Sodium Chloride
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk
Glycopyrrolate
Lack of Assurance of Sterility: Leaking/damaged syringes.
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