CVM is sharing this recall announcement because these products may be used in veterinary settings.
TOPIC: Dexmedetomidine Hydrochloride Injection by Fresenius Kabi: Recall - Due to Cross - Contamination of Lidocaine
AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy
ISSUE: Fresenius Kabi is recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg/mL), 50 mL fill in a 50 mL vial due to the possible presence of trace amounts of lidocaine in these two lots based on FDA investigation. Administration of Dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy could result in anaphylaxis, a potentially life-threatening condition.
To date, no adverse drug experience reports have been received for either of the lots being recalled by Fresenius Kabi.
BACKGROUND: Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is approved for intravenous use and indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.
List of recalled lots and product photos below:
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