Halt importation, distribution and usage of Bupivacaine – FDA warns


The Food and Drugs Authority (FDA), on Wednesday ordered hospitals and all concerned parties in the pharmaceutical supply chain to stop usage, importation, and distribution of unregistered heavy Marcaine 0.5 per cent injection (Bupivacaine).

This is to protect public health and safety; FDA statement signed by Mrs Delese A. A. Darko, the Chief Executive Officer and copied to the Ghana News Agency in Accra stated.

The statement said the product was unauthorized and unregistered, it has no English language as part of the label and Patient Information Leaflet.

According to the statement, the FDA had received a number of complaints for investigation on therapeutic ineffectiveness of Heavy Marcaine 0.5% injection (Bupivacaine) manufactured by Astra Zeneca/ Aspen which was being used in major health facilities in the Central and Greater-Accra Regions.

The statement said FDA has initiated investigations and yet to conclude on who was the importer of the product into the country.

Source: GNA