FDAClass IIApril 30, 2025

dexmedeTOMIDine HCl PF recall: Sterility Concern

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…

Why was dexmedeTOMIDine HCl PF recalled?

Lack of Assurance of Sterility: Leaking/damaged syringes.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 2431276A, Exp.: 4/20/2025

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…
Recalling firm
Denver Solutions, LLC DBA Leiters Health
Quantity
23,610 syringes
Distribution
Nationwide in the U.S.A
Recall date
April 30, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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