The WHO has issued a medical product alert for batches of eye ointment manufactured in India. The product was supplied to at least 55 countries under different labels.
A visual examination of random samples by five international recipients showed a range of quality issues within various batches (e.g. different shaped, sized and coloured particles on the nozzle, cap and in the ointment).
Currently there is no established evidence of any adverse effects caused by the affected batches.
The WHO advises authorities, healthcare professionals and the public to identify and withdraw all affected batches from circulation. Increased surveillance and diligence within the supply chains of affected countries and regions are critical. The manufacturer has initiated a voluntary recall for various batches.
National regulatory/health authorities are asked to immediately report to WHO if any affected batches are detected in their country.