Dexmedetomidine HCl injection syringes recalled for sterility loss risk
Denver Solutions is recalling 23,610 syringes of dexmedetomidine HCl injection due to leaking and damaged packaging that may compromise sterility. Affected patients should consult their healthcare provider.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving risk-of-harm (loss of sterility assurance due to physical damage to packaging). No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Denver Solutions, LLC, doing business as Leiters Health, is recalling dexmedetomidine HCl PF (parenteral formulation) in 0.9% sodium chloride, 20 micrograms per 5 mL single-dose syringes. The recalled product is identified by NDC 71449-131-11, lot #2431276A, with an expiration date of April 20, 2025. A total of 23,610 syringes have been distributed nationwide across the United States.
The recall was initiated due to lack of assurance of sterility. Some syringes in the affected lot were found to be leaking or damaged, which may compromise the sterility of the product. FDA has classified this as a Class II recall.
This product is a prescription medication used in healthcare settings. Healthcare providers and institutions that received syringes from this lot should stop using them immediately. Patients who may have received an injection from these syringes should contact their healthcare provider to discuss any potential exposure and appropriate follow-up care.
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
- Category
- Drug — Injectable
- Hazard
- sterility-loss
- contamination
- packaging-damage
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.
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