Fresenius Kabi USA, in cooperation with the U.S. Food and Drug Administration (FDA), issued a voluntary recall of two lots of dexmedetomidine HCl in 0.9 percent sodium chloride (NaCl) injection (product code: 671050/batch numbers: 6121853 and 6122207).
The solution, which is a human product that may be used by veterinarians, is approved for intravenous use and indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. The recalled formula might contain trace amounts of lidocaine, which could result in anaphylaxis in patients with an allergy.
The company, FDA says, is notifying its distributors and customers by letter and asking them to discontinue use and distribution of any affected product.
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