The National Agency for Food and Drug Administration and Control, NAFDAC, has issued a public warning about counterfeit OxyContin 80mg (oxycodone hydrochloride) tablets.
The counterfeit tablets were discovered on an unregulated market in Switzerland
The alert, labeled No. 07/2025, was posted on NAFDAC’s official website .
The agency highlighted that the issue was first reported to the World Health Organization by MUNDIPHARMA, the legitimate manufacturer, in February.
The falsified product was found to resemble the genuine OxyContin 80mg authorized for sale in Poland.
NAFDAC explained that OxyContin is a semi-synthetic opioid used for managing moderate to severe pain.
However, laboratory tests on the counterfeit tablets, conducted by Zurich’s Drug Information Centre (DIZ), disclosed that the tablets did not contain oxycodone. Instead, they were found to contain a synthetic opioid, likely a nitazene compound.
As stated by NAFDAC, nitazene derivatives (e.g., metonitazene, isotonitazene, fluonitazene) are highly potent synthetic opioids used primarily in research.
They are known for their high addiction potential and severe side effects. These compounds can be hundreds of times more potent than oxycodone, presenting a significant overdose risk.
Due to limited information on their toxicity, risks, and long-term effects, NAFDAC warned that using nitazenes could lead to fatal outcomes.
The agency emphasized that the falsified product is considered fraudulent because it misrepresents its identity, composition, and origin. MUNDIPHARMA confirmed that the product in question was not produced by their company.
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Furthermore, the counterfeit tablets contain undeclared nitazene compounds, posing a substantial risk of adverse events, even in small doses.
The high potency of these compounds is linked to several fatalities, especially when combined with other depressants like alcohol or benzodiazepines, which can lead to severe respiratory depression, coma, or death.
NAFDAC also noted that discrepancies in packaging were evident on the counterfeit tablets.
The batch and expiry dates on the falsified product were incorrectly placed on the front of the blister strip, while the legitimate OxyContin displays this information on the back.
In response to the discovery, NAFDAC has instructed its zonal directors and state coordinators to enhance surveillance and retrieve any falsified OxyContin tablets from circulation in Nigeria.
The agency has urged importers, distributors, retailers, healthcare professionals, and consumers to be cautious when handling OxyContin products and to avoid the sale or use of counterfeit medicines.
NAFDAC reminded the public that all medical products should be sourced from licensed suppliers, and consumers should verify the authenticity and condition of any medication before use.
Healthcare professionals and the public are encouraged to report any suspicious or substandard products to NAFDAC via their website, hotline (0800-162-3322), or email (sf.alert@nafdac.gov.ng).
Additionally, adverse reactions or side effects from medicinal products should also be reported to NAFDAC through its E-reporting platforms.
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