Dexmedetomidine vials recalled due to temperature abuse during distribution
McKesson Medical-Surgical is recalling Dexmedetomidine HCL single-dose vials due to temperature abuse during manufacturing or distribution that may have compromised product quality. No illnesses or injuries have been reported.
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 3/5 (High).
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: This is an FDA Class II recall involving a risk-of-harm product (injectable sedative) where temperature abuse may compromise drug efficacy or safety. Although no illnesses or injuries have been reported, the hazard is real and affects a high-risk medication used in medical settings.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Dexmedetomidine HCL Single Dose Vials (200 mcg per 2 mL, 100 mcg/mL) manufactured by Auromedics Pharma LLC. The vials are being recalled nationwide due to cGMP deviations involving temperature abuse during storage or distribution.
Temperature abuse can compromise the stability and effectiveness of the drug. Affected vials were distributed to healthcare facilities and providers across the United States. Individual recall letters have been sent to customers with information about the distribution dates of impacted product.
Healthcare professionals and patients should not use the recalled vials. Affected facilities should quarantine remaining stock and contact their supplier for return or replacement. Patients taking Dexmedetomidine from affected vials should consult their healthcare provider.
No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Dexmedetomidine HCL Single Dose Vial 200 mcg per 2 mL (100mcg/mL), Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0209-02
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable / Sedative
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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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