The FDA has said it was notified by Novo Nordisk on April 3 that several hundred units of counterfeit Ozempic (semaglutide) injection 1mg were found in the US drug supply chain.
The counterfeit products – which were distributed outside the Novo Nordisk authorised supply chain in the US – were seized by the FDA on April 9, according to its alert. Ozempic 1mg is FDA-approved to treat type 2 diabetes but has become a sought-after product due to its weight-loss properties.
"FDA and Novo Nordisk are testing the seized products and do not yet have information about the identity, quality or safety of these drugs," said the FDA, which added that its investigation is ongoing.
According to Novo Nordisk, the seized counterfeit products feature lot number PAR0362 as well as illegitimate serial numbers beginning with the first eight digits 51746517 (illustrated above).
Lot number PAR0362 is an authentic lot number. Only when both the lot number is coupled with the eight digits 51746517, it is counterfeit and should not be used.
The FDA is advising patients, wholesalers, retail pharmacies and healthcare professionals to check the Ozempic products they have received and not use, distribute or sell products labelled with the aforementioned numbers.
It also said it is aware of six adverse event reports associated with this lot, however, none of them appear to be associated with the counterfeit product and all six were reported by Novo Nordisk.
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