,
Public Alert No. 014/2023 – Alert on One Batch of Falsified Ozempic (Semaglutide) Pen in Nigeria.
The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public that one batch of Ozempic (Semaglutide) Pen confirmed to be falsified has been identified in Nigeria.
The Marketing Authorization Holder (MAH) Novo Nordisk has confirmed that Ozempic (Semaglutide) Injection Pen with batch number MP5B060 is falsified following an enquiry received from a customer about the product. Although no sample was returned to Novo Nordisk affiliate in Nigeria for investigation, the picture of the falsified product provided was scrutinized and the image of the pen in the picture was observed to be different from that in the genuine product confirming the falsified status of the suspected fake product.
According to the MAH, there were numerous cases related to the issue on falsified Ozempic originating from the Middle East and Russia. The affected countries include Azerbaijan, Egypt, Iraq, Jordan, Lebanon, Turkey, Uzbekistan and Russia.
Investigation conducted on the received falsified pens concludes that the pens are relabelled Apidra Solostar pen. The content of one of the pens was analysed and found to contain the fast-action insulin glulisin which is believed to be the case in all the falsified Ozempic pens identified. This implies the content of the falsified pens is entirely different from the genuine product.
The main difference between the counterfeit product and the genuine product is that the genuine Novo Nordisk Ozempic pens do not extend or increase in length when setting the dose. The scale drum increments are fixed doses, such as 0.25 mg, 0.5 mg, and 1.0 mg for Ozempic pens.
A falsified pen can be identified based on scale going from 0 to 80 units and extending out from the pen when setting the dose.
The falsified products have been sold both within the legal and illegal supply chain.
Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg is an injectable prescription medicine. It is a once-weekly medicine for adults with type 2 diabetes used to improve blood sugar, along with diet and exercise. It also helps to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes and known heart disease.
Images of the genuine and falsified Ozempic pens
Figure 1 and 2 below represents images of the genuine Ozempic pens;
Figure 1.
Figure 2.
Figure 3 and 4 are images of the reported falsified Ozempic Pens;
Figure 3. Figure 4.
Although the product is not in NAFDAC database, it is likely that it might have been distributed in the country through informal markets. NAFDAC implores importers, distributors, retailers and healthcare providers and patients to always exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and administration or use of falsified or substandard medicinal products. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
If you have this falsified product, please DO NOT use it. If you, or someone you know, have used the product, or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional.
Healthcare professionals and consumers are advised to report any suspicion of adverse drug reaction, substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
Healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal product 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
NAFDAC……….Customer-focused, Agency-minded!!!
Signed Management
