The National Agency for Food and Drug Administration and Control has alerted the public on falsified Oxycontin 80mg (oxycodone hydrochloride) which it says was detected in an unregulated market in Switzerland.
The public alert with No. 07/2025 was uploaded on the agency’s website on Thursday.
The agency said the issue about falsified medicine was reported to the World Health Organisation by the genuine manufacturer, MUNDIPHARMA, in February.
It said the falsified product imitated the genuine OXYCONTIN 80mg authorised for sale in Poland, adding that the genuine OXYCONTIN (oxycodone hydrochloride) is a semi-synthetic opioid indicated for the treatment of moderate to severe pain.
It said laboratory tests of samples for the falsified product were conducted by the Drug Information Centre in Zurich, Switzerland, and that WHO, DIZ’s drug-checking service determined that the tablets did not contain oxycodone but a synthetic opioid likely to be a nitazene compound.
According to NAFDAC, Nitazene derivatives (e.g., metonitazene, isotonitazene, fluonitazene) are potent synthetic opioids, primarily used in research due to their high addiction potential and severe side effects.
It said these substances could be hundreds of times stronger than oxycodone, posing a high overdose risk, stressing that limited information is available on their risks, toxicity, side effects, and long-term consequences.
“The identified product in this alert is confirmed as falsified on the basis that it deliberately/fraudulently misrepresented its identity, composition, or source.
“The falsified product imitates OXYCONTIN 80mg manufactured and marketed by MUNDIPHARMA in the Polish market. MUNDIPHARMA has confirmed that the product was falsified and was not produced by their company.
“This falsified product has been found to contain undeclared nitazene compounds, which pose a significant risk due to the high likelihood of adverse events, even in small doses. Nitazenes produce similar effects to other opioids.
“Their high potency carries a high risk of overdose and death. Using nitazene derivatives has been linked to several deaths.
“Mixing them with other depressants like alcohol or benzodiazepines can be very dangerous, leading to severe effects like respiratory depression, low blood pressure, coma, or even death,” NAFDAC said.
It said that this falsified product posed a particular risk to individuals with substance use disorders who might perceive this falsified product as a safe and quality-assured medicine.
NAFDAC said that visible discrepancies were observed on the falsified product such as the placement of the batch and expiry dates on the counterfeit product were incorrect.
It added that the falsified product batch and expiry date are visible on the front side of the blister strip, adding that genuine OXYCONTIN has the batch and expiry date visible on the back of the blister strip.
NAFDAC stated that on the falsified product, the expiry date is on the left and the batch number is on the right, pointing out that genuine OXYCONTIN has the batch number on the left and the expiry date on the right.
According to NAFDAC, all its zonal directors and state coordinators have been instructed to conduct surveillance and retrieve any falsified products of this medicine found within their zones and states in Nigeria.
It said that importers, distributors, retailers, healthcare professionals, and consumers are hereby advised to exercise caution and vigilance within the supply chain to avoid importation, distribution, sale, and use of falsified OXYCONTIN tablets.
NAFDAC said that all medical products/ medical devices must be obtained from authorised/licensed suppliers, stressing that products’ authenticity and physical condition should be carefully checked.
It advised healthcare professionals and consumers to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, or call NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng.
It said that 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.
NAFDAC said that healthcare professionals and patients could also report to the agency 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
NAN
