On Monday, Novo Nordisk A/S NVO mentioned it had turn out to be conscious of a number of hundred models of Ozempic (semaglutide) injection 1 mg distributed outdoors the Novo Nordisk approved provide chain within the U.S.
The seized counterfeit merchandise characteristic lot quantity PAR0362 and illegitimate serial numbers starting with the primary eight digits 51746517.
Lot quantity PAR0362 is an genuine lot quantity. Solely when the lot quantity is coupled with the eight digits 51746517 it’s counterfeit and shouldn’t be used.
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The U.S. Meals and Drug Administration (FDA) says that additional analyses, together with intensive visible examination and chemical testing of the seized counterfeit product, are underway because the investigation continues.
Accordingly, neither Novo Nordisk nor the FDA can verify the contents or high quality of the counterfeit product, which can current a security danger for sufferers who use the counterfeit product.
FDA and Novo Nordisk are testing the seized merchandise and don’t but have details about the medication’ id, high quality, or security.
Moreover, the evaluation discovered the needles from the samples have been counterfeit.
Accordingly, the sterility of the needles can’t be confirmed, which presents an elevated danger of an infection for sufferers who use counterfeit merchandise.
Primarily based on analyses accomplished to this point, the pen label, accompanying well being care skilled and affected person info, and carton are different confirmed counterfeit parts throughout the seized merchandise.
FDA is conscious of six opposed occasions from this lot, none of that are severe and are in keeping with recognized widespread opposed reactions to genuine Ozempic, that are nausea, vomiting, diarrhea, belly ache, and constipation.
Worth Motion: NVO inventory closed decrease by 2.38% at $64.49 on the final test Tuesday.
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