- The withdraw comes due to labeling the medicine for children instead of for adults
- The misleading info could lead to giving children double dose
The Ministry of Health and Prevention (MoHAP) has issued a circular withdrawing batch No.0093 of the pharmaceutical product (Laxocodyl suppositories10mg) after finding a mistake on the outside label.
The medicine label contained an incorrect information citing that the drug is for children” instead of “for adults”, making the dose unsafe for children, which could result in them having a double dose and suffering side effects.
The medicine was reportedly used for the treatment of constipation for adults and is manufactured by Julphar Gulf Pharmaceutical Industries Manufacturers In the form of suppositories.
As per the circular, the medicine, which is registered with ministry’s Drug Administration, will be withdrawn from the UAE market. All healthcare practitioners were advised not to use the medicine and all pharmacies were ordered not to dispense the medicine and to return it to the supplier.
Providing Alternative medicines
The ministry 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.
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.
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.
Report any side efforts to MoHAP
The ministry called on all suppliers, healthcare 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 e-mail to firstname.lastname@example.org 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 said 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 and achieve pharmaceutical and therapeutic quality, in addition to regulatory and supervisory services to govern and lead the health sector in the country.Email This Post