Nigerian drug regulator finds fatal toxin in 2 products from Mumbai, Punjab cos

Nigeria's National Agency for Food and Drugs Administration and Control (NAFDAC) has issued an alert about a substandard paracetamol suspension, Para Clear Suspension 125, which has been manufactured by Mumbai-based pharma company SyneCare.

NAFDAC, in a notification, says the product contains ethylene glycol, a toxic substance that is not expected in product formulations.

The product was imported by BVM Pharmaceutical, Liberia. "The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public of a substandard paracetamol suspension PARA CLEAR SUSPENSION 125 received from Liberian Medicine and Health Product Regulatory Authority for laboratory testing in the NAFDAC Central Drug Control Laboratory (CDCL)," the notification said.

The drug, paracetamol suspension, is used for the treatment of mild to moderate aches and pain, including headache, migraine, neuralgia, toothache, sore throat, and menstrual pains. It is also used for the reduction of fever and to be used as an adjunctive treatment to relieve symptoms of cold and flu.

The agency says the said product also failed the requirement for "acute oral toxicity with five deaths of the laboratory animals recorded".

Notably, diethylene glycol and ethylene glycol, both are considered "toxic to humans" when consumed and can prove fatal. The effect includes abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury, which may lead to death.

The product batch in question is L220008, with January 2022 as the manufacturing date and December 2024 as the expiry date. "Although the product is not in the NAFDAC database, 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 the substandard (contaminated) syrups," the NAFDAC has advised.

The agency has said anyone in possession of the above-mentioned product is advised to discontinue sale or use and submit stock to the nearest NAFDAC office.

The NAFDAC has also notified regarding a batch of "substandard (contaminated) Guaifenesin Syrup TG Syrup" in the Marshall Islands and Federated States of Micronesia, and reported to the World Health Organisation (WHO) on 6 April 2023. Guaifenesin is an expectorant used to relieve chest congestion and the symptoms of cough. It works by thinning and loosening mucus in the airways, clearing congestion, and making breathing easier.

The samples of the said product from the Marshall Islands were analysed by quality control laboratories of the Therapeutic Goods Administration (TGA) of Australia, which found the product contained unacceptable amounts of "diethylene glycol and ethylene glycol as contaminants".

The agency said the stated manufacturer of the affected product is QP Pharmachem Ltd, Punjab, India, while the stated marketer is Trillium Pharma (Haryana, India). "To date, neither the stated manufacturer nor the marketer has provided guarantees to WHO on the safety and quality of these products." The batch in question is SL-429 and has an expiry date of October 2023.