Ministry withdraws Augmentin 250mg for children due to manufacturing defect
Dubai: The Ministry of Health has issued a circular ordering medical institutions to withdraw Augmentin 250 mg for children (an antibiotic) due to a manufacturing error.
The product, made by GlaxoSmithKline, is said to contain small plastic particles in the packaging, which may mix with the medication.
The circular was issued to pharmacies, doctors, clinics, private and public hospitals to withdraw the medication with the manufacturing code 517999.
Dr Amin Hussain Al Amiri, Assistant Undersecretary at the Ministry for medical practice affairs and licensing, said the circular is in line with the ministry’s keenness to preserve public health and safety. He added that the product was pulled from the market as per the request of the manufacturers.
Al Amiri said the ministry has issued a ban on importing the product with the aforementioned manufacturing code, and that it has ordered GlaxoSmithKline to withdraw all products in the market.
He said that the company was asked to visit the Registration and Drug Control Department to provide a detailed report on the results of the withdrawal and the quantity of products that were pulled from the market, and to sign an undertaking to provide the same quantity of the medication to ensure that the market does not suffer from a shortage.
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