Dubai: The Ministry of Health and Prevention (MoHAP) has issued a circular withdrawing batch No. 0093 of the pharmaceutical product Laxocodyl suppositories 10mg after finding a mistake on their labels.
The medicine, manufactured by Julphar Gulf Pharmaceuticals, reportedly for treating constipation in adults, had an external label with incorrect information citing that the drug was for “children” instead of saying it was “for adults”, making the dose unsafe for children, which could result in them having a double dose and suffering side-effects.
As per the circular, the medicine, which is registered with MoHAP’s Drug Administration, will be withdrawn from the UAE market.
All health care practitioners have been advised not to use the medicine and all pharmacies have been ordered not to dispense the medicine and to return it to the supplier.
The ministry highlighted that the circular was addressed to directors of medical districts, public and private hospitals, doctors, pharmacists and pharmacists assistants, and managers of public and private pharmacies. It added that the circular was issued based on the Federal Law no. (4) of 1983 concerning the pharmacy profession and pharmaceutical institutions and the Ministerial Resolution No. (366) of 2010 governing the withdrawal, suspension, or prevention of circulation of pharmaceutical and medical products.
Providing alternative medicines
Going a step further in their due diligence, the ministry has also urged all members of the community not to use the said batch of the product, and to get rid of it, stressing the need to revisit their doctors or health care practitioners (pharmacist) to obtain other alternatives or use other batches of the product.
Monitoring pharmaceutical factories
The ministry affirmed that it closely monitors the local pharmaceutical factories, and in the event of any warning regarding any drugs, it immediately issues a circular to all health and concerned authorities ordering the withdrawal and disposal of these products in order to preserve the health and safety of the community.
It has called upon all suppliers, health care practitioners, pharmacists and community members to communicate with the ministry in the event of any side effects arising from the use of pharmaceutical products through sending an email to email@example.com or to report adverse effects through the online system on the ministry’s website or through the UAE RADR smartphone App.
The public can also view the circulars issued on the website of the Ministry.
The ministry also added that it will not hesitate to issue circulars to protect the society from side effects of counterfeit medicines and pharmaceutical counterfeiting, in accordance with its strategy to provide comprehensive and innovative health services. The aim of such circulars was to demonstrate due vigilance and achieve pharmaceutical and therapeutic quality, in addition to regulatory and supervisory services to govern and lead the health sector in the country.