The National Agency for Food and Drug Administration and Control (NAFDAC) is informing the public of the detection of a suspected counterfeit medicinal product found in the Nigerian market that infringes on the approved marketing authorization of Pulmicort® (Budesonide) manufactured by AstraZeneca. The information was provided to NAFDAC by AstraZeneca following market surveillance activities.
AstraZeneca reported that the identified suspected falsified product is marketed as “Ulmicort 0.5 mg/ml Inhalation Suspension”, bearing a name that closely resembles its registered product Pulmicort®, and may mislead healthcare professionals and patients.
Genuine Pulmicort® (budesonide) is an inhaled corticosteroid prescribed as a maintenance treatment to prevent asthma symptoms (such as wheezing and shortness of breath) and as prophylactic therapy.
Risk Statement
Counterfeit medicinal products may not meet the required standards of quality, safety, and efficacy. They may contain incorrect ingredients, improper quantities of active ingredients, contaminants, or may not contain the stated 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.
Product Details
The details of the suspected counterfeit products are as follows:
Product Information | Details |
Suspected Counterfeit Product | Ulmicort 0.5 mg/ml Inhalation Suspension |
Observed Location | Eastern Nigeria (Distributor Address: 15 Chizzon, Awada, Obosi North, Anambra State, Nigeria) |
Batch Number | 25770416E |
Manufacturing Date | June 2025 |
Expiry Date | May 2027 |
Labelled Manufacturer | Legency Remedies PVT Ltd, Vill Kalha Baddi, Tehsil Baddi, Distt Solan (H.P) 173205, India |
The genuine product is:
Genuine Product | Pulmicort® (Budesonide) Nebulising Suspension |
Product photos of genuine Pulmicort and the suspected counterfeit
NAFDAC is investigating the distribution and source of the suspected counterfeit products. All zonal directors and state coordinators have been directed to conduct surveillance and mop-up activities to identify and remove any counterfeit product from circulation in Nigeria.
Consumer Action
Consumers and healthcare professionals are advised to exercise caution to avoid the use of the counterfeit medicine and purchase medicines only from licensed pharmacies and authorized distributors. Product labels and packaging should be carefully examined before purchase and use.
Reporting of Adverse Events
Consumers and healthcare professionals are advised to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, call NAFDAC on 0800-162-3322, or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng , or via the Med- safety application available for download on Android and IOS stores, or via e-mail on pharmacovigilance@nafdac.gov.ng
For complaints, you can call the Reforms Unit on the following lines: 09097630506, 09097630507, or email: reforms@nafdac.gov.ng
NAFDAC…… Customer-Focused, Agency-Minded!!!
