The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert over a suspected counterfeit asthma medication circulating in Nigeria, warning that its use could lead to treatment failure and other severe health complications. The alert, shared on Friday via the agency’s official X account, identified the product as Ulmicort 0.5 mg/ml Inhalation Suspension, which was detected during a market surveillance operation conducted by pharmaceutical company AstraZeneca.
How the Counterfeit Was Detected
According to NAFDAC, AstraZeneca informed the agency that the suspected falsified product closely resembles its registered asthma medicine, Pulmicort (Budesonide) Nebulising Suspension. The resemblance is so striking that it could easily mislead healthcare professionals and patients into believing they are using the authentic medication.
Pulmicort is an inhaled corticosteroid commonly prescribed to prevent asthma symptoms such as wheezing and shortness of breath. It is used as a maintenance treatment for individuals living with asthma, a chronic respiratory condition that inflames and narrows the airways, leading to symptoms like coughing, chest tightness, and difficulty breathing.
Health Risks of Counterfeit Medicines
NAFDAC warned that counterfeit medicines often fail to meet the required standards of quality, safety, and efficacy. Such products may contain incorrect ingredients, the wrong quantity of active ingredients, harmful contaminants, or even no active ingredient at all. The agency emphasized that using these products can result in treatment failure, worsening of respiratory conditions, unexpected adverse effects, and other serious health consequences.
Asthma requires consistent and reliable treatment to keep symptoms under control. The use of a counterfeit inhaler not only deprives patients of the therapeutic benefit but also exposes them to potentially dangerous substances, making the alert particularly critical for the millions of Nigerians who rely on such medications.
Product Details and Origin
NAFDAC provided specific details about the suspected counterfeit product. It bears the batch number 25770416E, with a manufacturing date of June 2025 and an expiry date of May 2027. The product was reportedly found in Eastern Nigeria and traced to a distributor’s address at 15 Chizzon, Awada, Obosi North, in Anambra State.
The label on the suspected counterfeit indicates that it was manufactured by Legency Remedies PVT Ltd, located in Himachal Pradesh, India. NAFDAC has not confirmed whether this company is legitimate or if the label itself is falsified, but the agency has commenced an investigation to determine the source and distribution network of the medicine.
NAFDAC’s Response and Nationwide Action
In response to the discovery, NAFDAC has directed all its zonal directors and state coordinators to intensify surveillance and conduct mop-up operations to remove the product from circulation nationwide. This proactive measure aims to prevent the counterfeit medicine from reaching more patients and causing harm.
The agency has also called on consumers and healthcare professionals to purchase medicines only from licensed pharmacies and authorized distributors. They are urged to carefully examine product labels and packaging before use, looking for any signs of tampering or inconsistencies.
Advice to Consumers and Healthcare Professionals
NAFDAC encouraged the public to report any suspected cases of counterfeit or substandard medicines to the nearest NAFDAC office through its toll-free line, email, or online reporting platforms. Healthcare professionals and patients are also advised to promptly report any adverse reactions linked to medicinal products through the agency’s pharmacovigilance reporting channels.
This alert underscores the ongoing challenge of counterfeit pharmaceuticals in Nigeria, which pose significant risks to public health. NAFDAC’s swift action and public awareness efforts are crucial in mitigating these risks and ensuring that patients receive safe and effective treatments.
