The National Agency for Food and Drugs Administration and Control (NAFDAC) has warned healthcare providers and the public against the use of five oral liquid drugs produced in Pakistan.
The products identified as Alergo Syrup, Emidone Suspension, Mucorid Syrup, Ulcofin Suspension and Zincell Syrup are produced by Pharmix Laboratories (Pvt.) Ltd, a Pakistani drug maker.
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).
The routine screening detected unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
Laboratory testing conducted by the Therapeutic Goods Administration of Australia (TGA) confirmed that all five batches were contaminated with ethylene glycol at levels ranging from 0.62 to 0.82 percent relative to the accepted limit of not more than 0.10 percent.
A follow-on inspection of Pharmix Laboratories (Pvt.) Ltd was conducted by the Drug Regulatory Authority of Pakistan (DRAP).
According to DRAP, a review of the manufacturing facility and manufacturing records suggested that diethylene glycol and ethylene glycol as contaminants may be present in other products and batches manufactured by the company.
“The safety and quality of these products can, therefore, not be guaranteed. As a precautionary measure, Pharmix Laboratories has been instructed by DRAP to stop production of all oral liquid dosage medicines and issued a recall alert for the five different oral dosage forms manufactured by the company,” NAFDAC stated in an official alert.
Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.
The 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.
Manufacturers of liquid dosage forms, especially syrups that contain excipients at risk for contamination have been urged to follow GMP requirements and to test each container of incoming batch for ethylene glycol and diethylene glycol before using the excipients in the production of medicines.
According to NAFDAC, these substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death.
“Although these products are not registered by NAFDAC, they might have been distributed, through formal and informal markets, to other countries or regions including Nigeria,” the agency explained.
“NAFDAC implores importers, distributors, retailers and consumers to exercise caution and increase vigilance within the supply chain to avoid the importation, distribution, sale and use of the substandard cough syrups. All medical products must be obtained from authorized or licensed suppliers. The products’ authenticity and physical condition should be carefully checked.”
Healthcare professionals and consumers are advised to report any suspicion of adverse drug reactions, or substandard and falsified medicines to the nearest NAFDAC office, or via email: [email protected].
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of the medicinal product to the NAFDAC.
