Dexmedetomidine HCl Syringes Recalled for Potential Sterility Issue
Leiters Health is recalling dexmedetomidine HCl PF syringes nationwide due to leaking or damaged syringes that may not maintain sterility. Affected lot 2431276A has an expiration date of 4/20/2025.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a sterile drug product where the sterile integrity cannot be assured due to leaking or damaged syringes. Compromised sterility in injectable products presents a serious potential for infection or harm, meeting the Severe threshold.
Plain-English summary
Leiters Health is recalling dexmedetomidine HCl PF in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, supplied in 5mL single-dose syringes. The recall affects 23,610 syringes distributed nationwide in the U.S.A. The product is manufactured by Denver Solutions, LLC DBA Leiters Health.
The recall was initiated due to a lack of assurance of sterility. Some syringes in the affected lot have been found to be leaking or damaged, which could compromise the sterile integrity of the product.
The recalled lot is #2431276A with an expiration date of 4/20/2025. The product is supplied under NDC 71449-131-11. Healthcare providers and patients who have received this product should stop using it and contact their healthcare provider for guidance on appropriate replacement therapy.
The recalled product
- 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.
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Affected units
- 23,610
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 2431276A
- Exp.: 4/20/2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Denver Solutions, LLC DBA Leiters Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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