Two blood pressure products recalled

Rania Al Ghazzawi, Staff Reporter

The Department of Health-Abu Dhabi has instructed to withdraw all batches of two medicinal production used to treat high blood pressure from the markets of Abu Dhabi. This came based on reports confirming their inclusion of chemical impurities that may cause cancer to patients. However, the products are registered with the Ministry of Health and Prevention in the UAE.

In a circular issued to all health facilities and all health-care practitioners, the Department of Health explained that the manufacturer “Neopharma” has spontaneously withdrawn the product Arbitense 50 and 100mg Losartan Potassium tablet. They have been found containing over limit of “N-Nitroso-N-methyl-4-aminobutyric acid” which may cause cancer to the patients. The decision to suspend registration and withdrawal of batches of (BERESAR IRBESARTAN 75-150-300 MG), which is manufactured by Blue Pharma came based on a circular issued by the Saudi Food and Drug Administration (FDA). The circular was based on reports from international organisations indicating that the product might be containing impurities of N-NDEA, classified as impurities that are potentially carcinogenic.

The Department of Health requested the authorised agents of the New Medical Centre and Pharma stores to withdraw all batches at all concentrations from the markets. All pharmacies managers must stop discharge the mentioned products and return them to the supplier. Healthcare practitioners are also urged to report any side effects incurred  by the use of the mentioned products to the concerned departments. Last month, the Ministry of Health and Community Protection issued a circular withdrawing three batches of the vitamin d3 50000 iu capsule, used to strengthen bone. The General Organisation of Saudi Food and Drug Administration said there was a mistake in the therapeutic dose written on the package as it said the drug should be used once a day instead of once a week.

In a second circular issued by Dr Amin Al Amiri, Assistant Undersecretary for Public Health Policy and Licences, Chairman of the Higher Committee for Drug Awakening, the ministry withdrew sodium chloride.9% w /v, 250ml, used for loss of body water, because there is a leak in the packaging.