WHO Warns Of Severe Risks From Falsified Oxymorphone Hydrochloride Supply

This WHO Medical Product Alert concerns a batch of counterfeit Oxymorphone Hydrochloride 40mg tablets. Discovered within Finland's unregulated supply chain, the falsified batch was flagged by the Finnish Medicines Agency (FIMEA) and reported to WHO in July 2024. Oxymorphone Hydrochloride, a semi-synthetic opioid for moderate to severe pain, was found in these counterfeit tablets. However, lab tests revealed that they actually contained metonitazene instead. Metonitazene is a powerful synthetic opioid with no legitimate medical use. Classified as a Schedule I narcotic by international control based on WHO's 2021 recommendations, even small doses can cause severe respiratory depression, heavy sedation, addiction, and potentially fatal overdose.

This product is confirmed as falsified due to its intentional misrepresentation of identity, composition, and origin. The counterfeit product mimics Oxymorphone Hydrochloride from Aurolife Pharma, who have verified that the product mentioned in this alert is falsified and was not manufactured by them.

To spot this fake product, look for the following indicators:

The fake version's label lacks a barcode on the bottle.

It is labeled as 40mg, whereas Aurolife Pharma's Oxymorphone Hydrochloride is only available in 5mg and 10mg doses.

The counterfeit tablets do not have embossed letters or numbers.

The label on the fake product is missing the National Drug Code of the United States.

All medical products should only be sourced from authorized or licensed suppliers. Healthcare professionals are urged to report any adverse effects, unexpected outcomes, or suspected counterfeit products to their National Regulatory Authorities or National Pharmacovigilance Centre. WHO recommends heightened vigilance and monitoring within the supply chains of regions potentially impacted by these counterfeit products. Additionally, increased scrutiny of the informal and unregulated markets is advised. National regulatory authorities, health authorities, and law enforcement agencies are encouraged to promptly inform WHO if they identify the counterfeit product in their country.