Ministry of Health and Prevention withdraws pharmaceutical products due to non-compliance with approved specifications

Published Monday, 08 February 2021

The Ministry of Health and Prevention (MoHAP) has issued a decision withdrawing a number of pharmaceutical products manufactured by Julphar, the Gulf Pharmaceutical Industries PSC, after being found non-compliant with the approved specifications.

The ministry's move comes after samples of the suspected medicines were tested at the Quality Control Laboratory in Dubai especially as the manufacturer itself voluntarily recalled these drugs.

MoHAP instructed all pharmacies to stop dispensing these products and return them to the supplier, urging all health care practitioners and community members to refrain from using such products if they already in their possession.

The ministry listed the medicins voluntarily recalled as forte table, Julmentin 375mg tablet Julmentin which is used for treating bacterial infections and lungs, ears and sinuses infections, in addition to Mucolyte syrup, which is prescribed for mucous secretions, Butalin 2 and 4 mg tablet for bronchospasm, asthma and pulmonary embolism, and Lipigard 10mg tablet prescribed for treating cholesterol as well as Scopinal syrup, which is used for colon disorders, Supraproct s supp which is prescribed for haemorrhoids and rashes, and Gupisone 20 mg tablet which is used for allergies.

“The manufacturer has already been contacted and instructed to withdraw all batches of “Profenal”, which is analgesics, anti-inflammatories and antipyretics in children, due to non-conformity with the approved specifications in terms of the amount of the active substance, in addition to the existence of insoluble deposits on the top of the product's bottle wall that does not dissolve by shaking,” the ministry clarified.

Precautionary Measure

The ministry stated that the decision to voluntarily withdraw and suspend some pharmaceutical products was no more than a precautionary measure to ensure the health and safety of patients. It also came as part of periodic tests carried out on random products that are examined at the ministry’s national reference laboratory to support the drug system in the country and monitor the quality of medicines being used.

Top Priority

“We are closely following up on the withdrawal process and constantly coordinating with various international, regional and local pharmaceutical authorities and companies to keep abreast of any developments related to drug warnings,” the ministry said, affirming that the health and safety of the public is a top priority.

It urged all members of the public to get in touch with it through email at pv@moh.gov.ae, the ministry’s website or through the smart app UAE RADR in case they developed any side efforts if it happened and used the above-mentioned medicines. Those interested to learn about the latest circulars can visit the ministry’s website directly.

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