The World Health Organization (WHO) on Thursday issued an alert against several contaminated syrups and suspension medicines that have been identified in countries in the WHO regions of the Americas, the Eastern Mediterranean, South-East Asia and the Western Pacific.
According to the global health agency, the flagged products were manufactured by Pharmix Laboratories in Pakistan, the WHO said, and were first identified in the Maldives and Pakistan. Some of the affected products have also been detected in Belize, Fiji and Lao People’s Democratic Republic, it added.
The five products are ALERGO Syrup, EMIDONE Suspension, MUCORID Syrup, ULCOFIN Suspension and ZINCELL Syrup. A total of 23 batches of these products are affected. The stated manufacturer of all the affected products is PHARMIX LABORATORIES (PVT.) LTD (Pakistan).
In November 2023, samples of five different batches of ALERGO syrup were screened for non-compliance by the quality control laboratory of the Maldives Food and Drug Authority (MFDA) in accordance with the thin layer chromatography (TLC) test for Diethylene Glycol and Ethylene Glycol for inclusion in The International Pharmacopoeia.
“The routine screening detected potentially unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. Laboratory testing conducted by the Therapeutic Goods Administration of Australia confirmed that all five batches were contaminated with ethylene glycol at levels ranging from 0.62 to 0.82% w/w relative to the accepted limit of not more than 0.10% w/w,” the UN Health Body said in a statement.
A follow-on inspection of PHARMIX LABORATORIES (PVT.) LTD was conducted by the Drug Regulatory Authority of Pakistan (DRAP), it stated. “DRAP’s review of the manufacturing facility and manufacturing records suggests that diethylene glycol/ethylene glycol as contaminants may be present in other products and batches manufactured by PHARMIX LABORATORIES (PVT.) LTD. The safety and quality of these products can, therefore, not be guaranteed,” WHO revealed.
As a precautionary measure, PHARMIX LABORATORIES has been instructed by DRAP to stop production of all oral liquid dosage medicines, and on 16 November 2023, DRAP issued a Recall Alert for five different syrup medicines manufactured by PHARMIX LABORATORIES, WHO stated.
“To date, no reports of adverse effects linked to the affected products have been notified to WHO. However, while this Medical Product Alert specifically relates to products referenced in the Annex, out of an abundance of caution, WHO recommends increased vigilance and testing in respect of oral liquid dosage medicines produced by PHARMIX LABORATORIES (PVT.) between December 2021 and December 2022,” it added.
WHO also warned that the substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death.
“Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death,” it added.
