Alerts Overview
This WHO Medical Product Alert refers to one batch of falsified oxymorphone hydrochloride 40 mg. The counterfeit product was detected in an unregulated supply chain in Finland and reported to WHO in July 2024 by the Finnish Medicines Agency (FIMEA).
Oxymorphone hydrochloride is a semi-synthetic opioid used to treat moderate to severe pain. However, laboratory analysis of counterfeit samples revealed that the tablets contained metonitazene.
Metonitazene is a potent psychoactive synthetic opioid drug with no formally accepted medical or therapeutic use. It is controlled internationally as a Schedule I narcotic drug, following the recommendations of the WHO Expert Committee on Drug Dependence in 2021. Even small amounts can cause serious side effects, including respiratory depression, severe sedation and addiction, and overdose can be fatal.
How to spot this counterfeit
This product has been confirmed as counterfeit as it deliberately misrepresents its identity, composition and origin.
The counterfeit products are copies of oxymorphone hydrochloride sold by AUROLIFE PHARMA LLC, which has confirmed that the products covered by this warning are counterfeit and are not manufactured by the company.
To identify this counterfeit product, look for the following:
- The counterfeit label does not have a barcode on the bottle.
- Counterfeit products are labeled as 40 mg. AUROLIFE PHARMA Oxymorphone Hydrochloride is only available in 5 mg and 10 mg doses.
- The forged stone slabs have no embossed letters or numbers.
- The counterfeit products do not have the United States National Drug Code on their labels.
Detail is Annex For more information on counterfeit products, see the second half of this alert.
risk
This counterfeit product may have been intentionally designed to mimic a product approved by the U.S. Food and Drug Administration and sold by AUROLIFE PHARMA LLC as oxymorphone hydrochloride. However, this product contains undeclared metonitazene, which poses a significant risk to users as even small amounts have a high potential for side effects. Metonitazene has effects similar to other opioids. High potency There is an increased risk of overdose and death. Use of this counterfeit product can be life threatening.
Health professionals, regulators, and public
Healthcare professionals should report any occurrence of side effects, lack of the expected effect or suspected falsification to their national regulatory authority/national pharmacovigilance centre.
WHO recommends increased vigilance and vigilance within the supply chains of countries and regions potentially affected by these counterfeit products. Increased vigilance of informal/unregulated markets is also recommended. National regulatory/health/law enforcement agencies are encouraged to immediately notify WHO if counterfeit products are discovered in their country.
If you have these products in your possession, WHO recommends not using them. If you or anyone you know has used or may have used these products, or if you experience any adverse events or unexpected side effects after use, immediately seek medical advice from a healthcare professional or contact a poison control center.
All medical products should be obtained from authorized/licensed suppliers. If you have any information about the production or supply of these counterfeit products, please contact WHO at [email protected].
