The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted Nigerians to the circulation of a suspected counterfeit asthma medicine, warning that its use could lead to treatment failure and other serious health risks.
The agency made this known on Friday in a public alert shared on its official X account, saying the suspected falsified product, Ulmicort 0.5 mg/ml Inhalation Suspension, was detected during market surveillance conducted by pharmaceutical company AstraZeneca.
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According to NAFDAC, AstraZeneca informed the agency that the product closely resembles its registered asthma medicine, Pulmicort (Budesonide) Nebulising Suspension, and could mislead healthcare professionals and patients.
Pulmicort is an inhaled corticosteroid prescribed to prevent asthma symptoms such as wheezing and shortness of breath, and is used as a maintenance treatment for people living with asthma.
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Health risks
NAFDAC warned that counterfeit medicines may not meet the required standards of quality, safety and efficacy.
It explained that such products could contain incorrect ingredients, the wrong quantity of active ingredients, harmful contaminants, or no active ingredient at all.
“The use of such products can result in treatment failure, worsening of respiratory conditions, unexpected adverse effects and other serious health consequences,” the agency said.
Asthma is a chronic disease that affects the airways in the lungs, causing them to become inflamed and narrowed. It can lead to symptoms such as wheezing, coughing, chest tightness and difficulty breathing, and requires regular treatment to keep symptoms under control.
Product traced to Anambra
Providing details of the suspected counterfeit product, NAFDAC said it bears the batch number 25770416E, with a manufacturing date of June 2025 and an expiry date of May 2027.
It was reportedly found in Eastern Nigeria and traced to a distributor’s address at 15 Chizzon, Awada, Obosi North, Anambra State.
The agency added that the suspected counterfeit product is labelled as being manufactured by Legency Remedies PVT Ltd, located in Himachal Pradesh, India.
NAFDAC said it has commenced an investigation to determine the source and distribution network of the suspected counterfeit medicine.
The agency added that all its zonal directors and state coordinators have been directed to intensify surveillance and conduct mop-up operations to remove the product from circulation nationwide.
READ ALSO: NAFDAC blacklists Onifam Laboratories over regulatory violations
Advice to consumers
NAFDAC urged consumers and healthcare professionals to buy medicines only from licensed pharmacies and authorised distributors, and to examine product labels and packaging before use carefully.
The agency also encouraged the public to report suspected cases of counterfeit or substandard medicines to the nearest NAFDAC office via its toll-free line, email, or online reporting platforms.
It advised healthcare professionals and patients to promptly report any adverse reactions linked to medicinal products through its pharmacovigilance reporting channels.
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