Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cGMP deviations: Temperature abuse
Dexmedetomidine HCL Single Dose Vial 200 mcg per 2 mL (100mcg/mL), Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0209-02
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Reason Cross Contamination with other products: trace amounts of lidocaine
Reason Cross Contamination with other products: trace amounts of lidocaine
Reason Lack of sterility assurance.
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
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