Other safety alerts
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| The United States: FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in US drug supply chain |
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The US Food and Drug Administration (FDA) announces that it continues to investigate counterfeit Ozempic (semaglutide) injection 1 milligram (mg) in the legitimate United States drug supply chain and has seized thousands of units of the product. The agency advises wholesalers, retail pharmacies, health care practitioners and patients to check the product they have received and not distribute, use, or sell products labeled with lot number NAR0074 and serial number 430834149057. Some counterfeit products may still be available for purchase.
FDA and Novo Nordisk (manufacturer of Ozempic) are testing the seized products and do not yet have information about the drugs’ identity, quality or safety.
Additionally, analysis found the needles from the samples are counterfeit. Accordingly, the sterility of the needles cannot be confirmed, which presents an increased risk of infection for patients who use the counterfeit products. Based on analyses completed to date, other confirmed counterfeit components within the seized products are the pen label, accompanying health care professional and patient information and carton.
FDA is aware of five 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.
FDA’s investigation is ongoing, and the agency is working with Novo Nordisk to identify, investigate and remove further suspected counterfeit semaglutide injectable products found in the United States.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-use-counterfeit-ozempic-semaglutide-found-us-drug-supply-chain
In Hong Kong, Ozempic Solution For Injection In 3.0ml Pre-filled Pen 1mg/dose (HK-66487) is a pharmaceutical product registered by Novo Nordisk Hong Kong Ltd. The product is a prescription-only medicine. The packaging of the counterfeit Ozempic product mentioned in the above FDA’s announcement is different from the registered packaging of the product in Hong Kong.
Ends/Friday, Dec 22, 2023
Issued at HKT 15:00
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