Regulatory Affairs
NAFDAC Alerts Nigerians to Suspected Counterfeit Pulmicort Product Detected in Eastern Nigeria
NAFDAC has alerted Nigerians to a suspected counterfeit Pulmicort (budesonide) product marketed as “Ulmicort 0.5 mg/ml Inhalation Suspension”, detected in Eastern Nigeria and currently under investigation.
The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted Nigerians to a suspected counterfeit medicine marketed as “Ulmicort 0.5 mg/ml Inhalation Suspension”, which the agency says closely mimics AstraZeneca’s registered Pulmicort® (budesonide).
The suspected falsified product was identified in Eastern Nigeria following market surveillance conducted by AstraZeneca, which subsequently provided the information to NAFDAC.
According to the agency, the product bears a name closely resembling Pulmicort and could mislead healthcare professionals and patients into believing that it is the genuine medicine.
Suspected Ulmicort identified in Eastern Nigeria
NAFDAC said the suspected product was observed in Eastern Nigeria and carries batch number 25770416E.
The product states a manufacturing date of June 2025 and an expiry date of May 2027. Its label identifies the manufacturer as Legency Remedies PVT Ltd, Vill Kalha Baddi, Tehsil Baddi, District Solan, Himachal Pradesh, India.
NAFDAC identified the genuine medicine as Pulmicort® (budesonide) Nebulising Suspension, manufactured by AstraZeneca.
The agency's alert includes photographs comparing the genuine Pulmicort product with the suspected counterfeit to assist healthcare professionals and consumers in identifying the affected product.
Why the alert matters
Pulmicort contains budesonide, an inhaled corticosteroid used as maintenance treatment to help prevent asthma symptoms and as prophylactic therapy.
Because the suspected product is presented as an inhalation suspension, any substitution or confusion at the point of dispensing could have implications for patients who depend on inhaled corticosteroid therapy for respiratory disease management.
NAFDAC warned that counterfeit medicinal products may fail to meet required standards of quality, safety and efficacy. They may contain an incorrect ingredient, an inappropriate quantity of the active ingredient, contaminants or no stated active ingredient at all.
The use of such products can result in treatment failure, worsening of respiratory conditions, unexpected adverse effects and other potentially serious health consequences.
NAFDAC orders surveillance and mop-up
NAFDAC said it is investigating the source and distribution of the suspected counterfeit product.
The agency has directed its zonal directors and state coordinators to conduct surveillance and mop-up operations to identify and remove any affected products from circulation.
The development reinforces the importance of maintaining vigilance within the pharmaceutical supply chain, particularly when sourcing medicines for patients with chronic respiratory conditions.
Advice for pharmacists and patients
NAFDAC advised consumers and healthcare professionals to exercise caution and avoid the suspected medicine.
Patients should obtain medicines from licensed pharmacies and authorised distributors, while pharmacists and other healthcare professionals should carefully examine product packaging, labelling and other identifying details before dispensing.
Any product suspected to be falsified should be withheld from use or dispensing and reported to NAFDAC for appropriate investigation.
Patients who are uncertain about the authenticity of a medicine should consult a pharmacist or other qualified healthcare professional rather than relying solely on the appearance or name of the product.
How to report suspected falsified medicines
Consumers and healthcare professionals can report suspected substandard or falsified medicines to the nearest NAFDAC office.
NAFDAC also provided 0800-1-623322 for reports and sf.alert@nafdac.gov.ng for suspected substandard and falsified medicines.
Suspected adverse events or side effects associated with medicines can also be reported through NAFDAC's pharmacovigilance reporting channels, including its electronic reporting platforms and the Med Safety application.
Investigation ongoing
NAFDAC has classified the product as a suspected counterfeit and said investigations into its source and distribution are ongoing.
The agency's alert does not establish the full extent of the product's distribution in Nigeria or indicate how many patients may have encountered it.
For pharmacists and other healthcare professionals, the alert underscores the importance of verifying medicines obtained through the supply chain and promptly reporting suspicious products to the regulator.
Further updates from NAFDAC will be important as the investigation and market surveillance activities continue