Counterfeit Ozempic Identified in US Supply Chain With Fake Labels And Needles, FDA Alerts

On Monday, Novo Nordisk A/S NVO said it had become aware of several hundred units of Ozempic (semaglutide) injection 1 mg distributed outside the Novo Nordisk authorized supply chain in the U.S.

The seized counterfeit products feature lot number PAR0362 and illegitimate serial numbers beginning with the first eight digits 51746517.

Lot number PAR0362 is an authentic lot number. Only when the lot number is coupled with the eight digits 51746517 it is counterfeit and should not be used.

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The U.S. Food and Drug Administration (FDA) says that further analyses, including extensive visual examination and chemical testing of the seized counterfeit product, are underway as the investigation continues.

Accordingly, neither Novo Nordisk nor the FDA can confirm the contents or quality of the counterfeit product, which may present a safety risk for patients who use the counterfeit product.

FDA and Novo Nordisk are testing the seized products and do not yet have information about the drugs' identity, quality, or safety.

Additionally, the analysis found the needles from the samples were counterfeit.

Accordingly, the sterility of the needles cannot be confirmed, which presents an increased risk of infection for patients who use counterfeit products.

Based on analyses completed to date, the pen label, accompanying health care professional and patient information, and carton are other confirmed counterfeit components within the seized products. 

FDA is aware of six adverse events from this lot, none of which are serious and are consistent with known common adverse reactions to authentic Ozempic, which are nausea, vomiting, diarrhea, abdominal pain, and constipation.

Price Action: NVO stock closed lower by 2.38% at $64.49 at the last check Tuesday.

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