NAFDAC issues product alert over contaminated syrup manufacturer in India

The National Agency for Food and Drugs Administration and Control (NAFDAC) has issued a product alert over contaminated syrup by an Indian manufacturer, warning that it is unsafe for use, especially in children, and may result in serious injury or death.

NAFDAC issued a statement notifying healthcare providers that a batch of substandard Guaifenesin Syrup (TG Syrup) has been identified in the Marshall Islands and the Federated States of Micronesia and reported to WHO on April 6.

The commission said samples of the guaifenesin syrup TG syrup from the Marshall Islands were analysed by quality control laboratories of the Therapeutic Goods Administration (TGA) of Australia.

The analysis, however, found that the product contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.

The stated manufacturer of the affected product is QP Pharmachem Ltd. (Punjab, India), and the stated marketer of the product is Trillium Pharma (Haryana, India).

“To date, neither the stated manufacturer nor the marketer has provided guarantees to the WHO on the safety and quality of these products,” NAFDAC said.

It stated that guaifenesin is an expectorant used to relieve chest congestion and the symptoms of coughing. It works by thinning and loosening mucus in the airways, clearing congestion, and making breathing easier.”

“Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.

Public Alert No. 19/2023.
Alert on substandard (contaminated) syrup medicines identified in WHO region of the Western Pacific.#NafdacAlertshttps://t.co/cRU9lJeKgN pic.twitter.com/Omx0CCOUz4

— NAFDAC NIGERIA (@NafdacAgency) June 19, 2023

“The contaminated guaifenesin syrup is unsafe, and its 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.”

NAFDAC, however, urged manufacturers of liquid dosage forms, especially syrups that contain excipients such as propylene glycol, polyethylene glycol, and sorbitol, to test for the presence of contaminants such as ethylene glycol and diethylene glycol before use in medicines.

“Please note that the product is not in NAFDAC database. However, importers, distributors, retailers, and consumers are advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and use of substandard (contaminated) syrups. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.” it added.

The commission also urged the public in possession of the above-mentioned product to discontinue sale or use and submit stock to the nearest NAFDAC office.