According to an FDA-posted recall notice and the MiamiHerald, Fresenius Kabi USA is recalling one batch of its Dexmedetomidine HCl in 0.9% Sodium Chloride Injection due to lidocaine contamination. If a patient is allergic to lidocaine and receives the Dexmedetomidine HCl containing lidocaine, a potentially life-threatening allergic reaction could happen. Dexmedetomidine HCl is a medication that is given to patients intravenously before or during surgical or medical procedures.
According to a Fresenius statement, “Administration of Dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy could result in a potentially life-threatening allergic reaction.”
The lot that is being recalled was delivered to distributors, wholesalers, pharmacies, and hospitals from April 9, 2000, until April 13, 2020. The recalled lot has a batch Number of 6123925 and has an expiration date of March 2022.
The FDA states that if you or a loved one suffer a medical problem caused by this medication or any other medicine, first to seek medical attention. Then report the problem to the FDA’s MedWatch Adverse Event Reporting Program.
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