Batch recall of Propranolol Hydrochloride Injection 1mg/ml

On 16 August 2014, the Department of Health (DH) endorsed a licensed drug wholesaler, Vantone Medical Supplies Co Ltd (Vantone), to voluntary recall one batch of Propranolol Hydrochloride Injection 1mg/ml from the market due to potential quality issue. The batch under recall is 6007698 (Expiry date: March 2016).

Vantone notified DH on 16 August 2014 that the manufacturer of the product in USA has initiated a recall of the batch of the product as a precautionary measure because the manufacturer of the active ingredient has been found to have violated the Good Manufacturing Practice requirements. Such violation may introduce risk of cross-contamination of the active ingredient. So far, no adverse event related to the use of the product has been received.

Propranolol Hydrochloride Injection 1mg/ml, containing propranolol hydrochloride, is a prescription medicine used for the treatment of cardiac arrhythmias.

In Hong Kong, Propranolol Hydrochloride Injection is not a registered pharmaceutical product. However, Vantone has imported 340 vials of the affected batch in July 2014 for the treatment of particular patients. DH will closely monitor the recall.