The agency has seized thousands of units of counterfeit Ozempic doses from the U.S. drug supply chain since launching an investigation this fall. An analysis revealed needles included in the seized products are also counterfeit.
“Accordingly, the sterility of the needles cannot be confirmed, which presents an increased risk of infection for patients who use the counterfeit products,” the agency said Dec. 21.
The FDA has received five reports of adverse events from the counterfeit products, which were not severe and similar to known Ozempic reactions.
Some counterfeit products may still be available for purchase, the agency said. Healthcare providers and pharmacies should be alert for affected units and only purchase Ozempic through authorized Novo Nordisk distributors.
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