The National Agency for Food and Drugs Administration and Control (NAFDAC) has issued an alert to healthcare providers and the public regarding five different oral liquid dosage forms (syrup and suspension) discovered in the Maldives and Pakistan.
These products have also been identified in Belize, Fiji, and the Lao People’s Democratic Republic.
The affected products are ALERGO Syrup, EMIDONE Suspension, MUCORID Syrup, ULCOFIN Suspension, and ZINCELL Syrup, totaling 23 batches, all originating from the manufacturer PHARMIX LABORATORIES (PVT.) LTD in Pakistan.
The alarm was sounded when samples of ALERGO syrup were screened in November 2023 by the Maldives Food and Drug Authority, revealing potentially harmful levels of diethylene glycol and ethylene glycol contaminants.
Further testing by the Therapeutic Goods Administration of Australia confirmed ethylene glycol contamination in all five batches.
Public Alert No. 037/2023.
Alert on substandard (contaminated) syrup and suspension medicines identified in the WHO regions of the Americas, Eastern Mediterranean, South-East Asia, and Western Pacific.#NafdacALERTShttps://t.co/NPjRnRHNBz pic.twitter.com/1x4jxCFU7o— NAFDAC NIGERIA (@NafdacAgency) December 29, 2023
What you should know
- A subsequent inspection by the Drug Regulatory Authority of Pakistan raised concerns about the broader product range of PHARMIX LABORATORIES, prompting a halt in the production of all oral liquid dosage medicines and a recall alert for the five identified oral dosage forms.
- Both diethylene glycol and ethylene glycol are highly toxic to humans and can result in severe health complications, including abdominal pain, vomiting, altered mental state, and acute kidney injury. In some cases, ingestion can be fatal.
- While these products are not registered by NAFDAC, there is a possibility of their distribution through formal and informal markets to other countries, including Nigeria.
- NAFDAC emphasizes the importance of caution and increased vigilance within the supply chain to prevent the importation, distribution, sale, and use of these substandard cough syrups.
- Importers, distributors, retailers, and consumers are urged to verify the authenticity and physical condition of medical products obtained from authorized/licensed suppliers.
- NAFDAC further advises against the sale or use of the listed products and encourages individuals in possession of these items to submit them to the nearest NAFDAC office.
For those who have used the affected products and experienced adverse reactions, immediate medical advice from qualified healthcare professionals is strongly recommended.
NAFDAC calls on healthcare professionals and consumers to report any suspicions of adverse drug reactions, substandard, or falsified medicines to the nearest NAFDAC office or through various reporting platforms, including a toll-free number and email.
Additionally, the public is encouraged to report adverse events or side effects related to medicinal product use through the NAFDAC website, the Med-safety application on Android and iOS stores, or email.
Heightened awareness and swift reporting are pivotal in ensuring the safety and integrity of medical products within the Nigerian market.
