Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of sterility assurance.
Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
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 cGMP deviations: Temperature abuse
Reason Cross Contamination with other products: trace amounts of lidocaine
Reason Cross Contamination with other products: trace amounts of lidocaine
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
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