Fresenius Kabi announced another voluntary recall of a single lot of injectable dexmedetomidine hydrochloride, due to cross-contamination with lidocaine.
The recalled lot — Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg /mL), 50 mL fill in a 50 mL vial — is approved for intravenous use and indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.
Back in July, the German-based generic drugmaker recalled two lots of injectable dexmedetomidine HCl for the same reason — potential traces of lidocaine.
Administration of the recalled product to a patient with lidocaine allergy could potentially result in anaphylaxis if trace amounts of lidocaine are present. The company says that to date, no adverse drug experience reports have been received for the recalled lot.
Read the recall announcement
