The Recall Registry
Recall data checked 7 hours ago

Home Prescription medicine Denver Solutions, LLC DBA Leiters Health —…

Food & drug recall · FDAMarch 31, 2025Serious

Denver Solutions, LLC DBA Leiters Health — 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

Do not stop taking this without speaking to your pharmacist or doctor.

What’s wrong

Lack of Assurance of Sterility: Leaking/damaged syringes.

The Recall Registry rates this seriousFDA Class II: temporary or medically reversible health harm.

What to do

Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.

Who to contact: Recalling firm: Denver Solutions, LLC DBA Leiters Health

The product

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.

Details

Units affected
23,610 syringes
Recall date
March 31, 2025
Brand
Denver Solutions, LLC DBA Leiters Health
Model, lot or SKU numbers
Lot #: 2431276A, Exp.: 4/20/2025
Where it was distributed

Nationwide in the U.S.A

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

Their exact wording: Denver Solutions, LLC DBA Leiters Health — 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-

Read it on FDA

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Prescription medicine

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