As counterfeit Ozempic circulates within the U.S., the Meals and Drug Management has issued a caution to American citizens.
In an April 14 announcement, the FDA said that Novo Nordisk — producer of Ozempic and Wegovy — notified the company that “a number of hundred gadgets of counterfeit Ozempic (semaglutide) injection 1 mg” have been within the U.S. drug provide chain.
Ozempic is an injectable medicine licensed to regard sort 2 diabetes. Wegovy, the similar drug however at the next dose, is licensed to treat obesity.
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“The counterfeit merchandise have been allotted out of doors the Novo Nordisk licensed provide chain within the U.S.,” the FDA said in its announcement. “FDA seized the recognized counterfeit merchandise on April 9, 2025.”
Any medicines categorized with lot quantity PAR0362 and with a serial quantity beginning with the primary 8 digits 51746517 will have to now not be used, bought or allotted, in step with the FDA. (Meals and Drug Management)
The FDA has urged sufferers, wholesalers, retail pharmacies and healthcare professionals to test any Ozempic merchandise of their ownership.
Any medicines categorized with lot quantity PAR0362 and with a serial quantity beginning with the primary 8 digits 51746517 will have to now not be used, bought or allotted, in step with the company.
“FDA is conscious about six opposed tournament reviews related to this lot. Alternatively, none of them seem to be related to the counterfeit product,” the commentary stated. “All six opposed occasions have been reported by means of Novo Nordisk.”
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Dave Moore, government vp of US operations and President of Novo Nordisk Inc., supplied the beneath commentary to Fox Information Virtual.
“At Novo Nordisk, patient safety is our most sensible precedence, and we take the rising choice of incidents involving counterfeit variations of Ozempic very severely,” he stated.
The FDA has urged sufferers, wholesalers, retail pharmacies and healthcare execs to test any Ozempic merchandise of their ownership. (iStock)
“It’s gravely regarding, and we do all we will be able to to alert sufferers, healthcare execs, wholesalers and retail pharmacies about counterfeit incidents once they stand up.”
The seized merchandise are lately being examined by means of the FDA and Novo Nordisk to resolve the id, high quality or protection of the medication.
The FDA’s investigation is ongoing, the company added.
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Dr. Brett Osborn, a Florida neurosurgeon and longevity doctor who has prescribed semaglutide medicines to his sufferers, has prior to now spoken concerning the risks of inexpensive, counterfeit variations.
“Because of the price of brand-name Ozempic, an increasing number of individuals are turning to inexpensive knock-off variations, steadily discovered on-line or via non-regulated channels,” he instructed Fox Information Virtual.
“You will have to simplest be the use of pharmaceutical-grade variations prescribed by means of a authorized physician.”
“Those knock-offs are synthesized in non-medical environments with out the important high quality assurance or high quality keep an eye on, making them inherently dangerous.”
Those medicines may also be damaging when there’s no oversight in their supply or manufacturing high quality, Osborn warned.
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“After they’re made in unregulated environments, there is no telling what you’re hanging into your frame.”
Medicines like Ozempic require “precision in production,” in step with Osborn.
Ozempic is an injectable medicine licensed to regard sort 2 diabetes. Wegovy, the similar drug however at the next dose, is licensed to regard weight problems. (Getty Photographs)
“You will have to simplest be the use of pharmaceutical-grade variations prescribed by means of a licensed doctor,” he stated.
“The danger with those variants is just too top, and there’s no law to make sure they’re made correctly.”
Other folks will have to use warning when ordering any medicine on-line, medical doctors agree.
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“Until you’re getting the drugs from a certified pharmacy with a valid prescription from a physician, buying Ozempic or its knockoffs on-line is unhealthy,” Osborn warned. “You’ll be able to’t examine the product’s supply, elements or protection.”
The seized merchandise are lately being examined by means of the FDA and Novo Nordisk to resolve the id, high quality or protection of the medication. (iStock)
Osborn reiterated that medicines like Ozempic will have to simplest be prescribed by means of a doctor authorized to write down prescriptions — “now not a nurse practitioner by means of a telemedicine consult with or a chiropractor.”
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“When used appropriately, those medicines are tough gear, however may also be unhealthy within the incorrect arms,” he stated.
“At all times seek the advice of a healthcare supplier with the correct coaching and enjoy in the use of those medicines. Protection first.”
