The National Agency for Food and Drugs Administration and Control (NAFDAC) has raised alarms about a batch of contaminated syrup produced by an Indian manufacturer, warning of its potential dangers, particularly for children, and the potential for severe harm or even death.
In response to reports from the World Health Organization (WHO) on April 6, NAFDAC issued a statement advising healthcare providers about the discovery of substandard Guaifenesin Syrup (TG Syrup) in the Marshall Islands and the Federated States of Micronesia.
Laboratory tests conducted by the Therapeutic Goods Administration (TGA) of Australia on samples of the guaifenesin syrup from the Marshall Islands unveiled the presence of unacceptable levels of diethylene glycol and ethylene glycol as contaminants.
The manufacturer identified in connection with the affected product is QP Pharmachem Ltd. based in Punjab, India, while Trillium Pharma, located in Haryana, India, is the stated marketer of the product.
“Despite being notified, neither the manufacturer nor the marketer has provided WHO with adequate assurances regarding the safety and quality of these products,” cautioned NAFDAC.
Guaifenesin syrup is commonly used as an expectorant to alleviate chest congestion and cough symptoms by thinning and loosening mucus, thereby clearing airways and facilitating easier breathing.
However, diethylene glycol and ethylene glycol are toxic to humans when ingested and can potentially be fatal.
The contaminated guaifenesin syrup is considered unsafe, especially for children, as its usage may lead to severe injuries or even death. Toxic effects may include abdominal pain, vomiting, diarrhea, inability to urinate, headaches, changes in mental state, and acute kidney injury, which could prove fatal.
NAFDAC has urged manufacturers of liquid dosage forms, particularly syrups containing excipients like propylene glycol, polyethylene glycol, and sorbitol, to conduct thorough testing for the presence of contaminants such as ethylene glycol and diethylene glycol before incorporating them into medications.
“It’s important to note that the product in question is not listed in the NAFDAC database. Nonetheless, importers, distributors, retailers, and consumers are advised to exercise caution and remain vigilant throughout the supply chain to prevent the importation, distribution, sale, and use of substandard (contaminated) syrups,” added NAFDAC.
The agency also appealed to the public to immediately cease selling or using the aforementioned product and to surrender any existing stock to the nearest NAFDAC office.
Furthermore, it emphasized the importance of procuring all medical products exclusively from authorized and licensed suppliers, recommending thorough verification of product authenticity and physical condition.
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