• Spain Health recalls four batches of an antibiotic after detecting an impurity "above the established limit"

The World Health Organization (WHO) has warned of the presence of contaminated syrups and suspended medicines that they have identified in the Americas, the Eastern Mediterranean, Southeast Asia and the Western Pacific.

This WHO alert refers to five syrups and suspended drugs initially detected in the Maldives and Pakistan and notified to the entity on November 8. Some of the affected products have also been detected in Belize, Fiji and Laos.

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 declared manufacturer of all affected products is Pharmix Laboratories (Pvt) Ltd, based in Pakistan.

Last November, the Maldives Food and Drug Authority's (MFDA) quality control laboratory analysed samples from five different batches of 'Alergo' syrup. The routine test detected "potentially unacceptable amounts" of diethylene glycol and ethylene glycol contaminating the drugs.

Laboratory tests conducted by the Australian Therapeutic Goods Administration confirmed that all five batches were contaminated with ethylene glycol at levels ranging from 0.62 to 0.82% w/w (percentage/w) relative to the accepted levels, the limit of which must exceed 0.10% w/w.

As a result, the Pakistan Medicines Regulatory Authority (DRAP) conducted a follow-up inspection of Pharmix Laboratories, both the facility and manufacturing records, which suggests that diethylene glycol and ethylene glycol "may be present in other products and batches manufactured" by the company. Therefore, according to the WHO, "the safety and quality of these products cannot be guaranteed."

As a precautionary measure, the Regulatory Authority ordered Pharmix to stop production of all oral liquid dosage medicines. In addition, on November 16, it issued a recall alert for five syrups manufactured by Pharmix Laboratories.

Fatal risk

On the other hand, contaminated products may have been distributed, through formal and informal markets, to other countries. To date, no reports of adverse effects related to the affected products have been reported to WHO.

But, out of an abundance of caution, WHO recommends increased surveillance and testing regarding oral liquid dosage medicines produced by Pharmix Laboratories between December 2021 and December 2022.

In addition, the WHO reiterated that diethylene glycol and ethylene glycol "are toxic to humans when consumed and can be fatal" and stressed that the contaminated products referred to in this alert "are not safe and their use, especially in children, can result in serious injury or death."

As for the symptoms of intoxication, abdominal pain, vomiting, diarrhea, inability to urinate, headache, altered mental status, as well as acute kidney injury, which can lead to death, stand out.

Finally, the institution recommends not using any of the affected products and calls for increased vigilance in supply chains. Increased surveillance of the informal or unregulated market is also advised and national regulatory authorities and health authorities are advised to "immediately" notify WHO if they discover such contaminated products in their respective countries.

  • WHO
  • Pharmacology