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Ostrzeżenia FDA dotyczące leków
OSTRZEŻENIA FDA DOTYCZĄCE LEKÓW
DEC
10
MediNatura New Mexico, Inc. Issues Voluntary Nationwide Recall of ReBoost Nasal Spray Due to Microbial Contamination
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on
DEC
10
Audience: Consumer December 10, 2025 – Albuquerque, New Mexico, MediNatura New Mexico, Inc. is voluntarily recalling one lot of ReBoost Nasal Spray to the consumer level. The product has been found to contain yeast/mold and microbial...
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DEC
05
Novo Nordisk Warns Consumers About Counterfeit Ozempic (semaglutide) Injection 1 mg in the US
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on
DEC
05
Audience: Consumer PLAINSBORO, NJ, December 5, 2025 - FDA recently seized dozens of units of counterfeit Ozempic (semaglutide) injection 1 mg distributed illegally outside of Novo Nordisk’s authorized supply chain. The US Food and Drug...
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DEC
02
FDA Seizes 7-OH Opioids to Protect American Consumers
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on
DEC
02
Audience: Consumers December 2, 2025 -- The U.S. Food and Drug Administration, in coordination with the U.S. Department of Justice, announced today that the U.S. Marshals Service seized approximately 73,000 units of 7-hydroxymitragynine (7-OH)...
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NOV
21
FDA Investigating Death Due to Neutralizing Antibodies to ADAMTS13 following Adzynma Treatment of Congenital Thrombotic Thrombocytopenic Purpura
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on
NOV
21
Audience: Health Care Professional FDA Safety Communication – November 21, 2025 Summary of the Issue Since approval, the Food and Drug Administration (FDA) has received postmarketing reports of neutralizing antibodies to ADAMTS13...
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NOV
14
FDA Issues New Boxed Warning for Acute Serious Liver Injury and Acute Liver Failure Following Treatment with Elevidys and Revised Indication
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on
NOV
14
Audience: Health Care Professional FDA Safety Communication – November 14, 2025 Summary of the Issue In June 2025, FDA issued a safety communication, “FDA Investigating Deaths Due to Acute Liver Failure in Non-ambulatory Duchenne...
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NOV
10
FDA Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies
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on
NOV
10
Audience: Health Care Professional, Consumer November 10, 2025 -- Today, the U.S. Food and Drug Administration (FDA) informed application holders of menopausal hormone therapies (MHT), also commonly referred to as Hormone Replacement Therapy (HRT)...
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NOV
06
Fresenius Kabi Issues Voluntary Nationwide Recall of Three Lots of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial Due to Out-of-Specification Endotoxin Results in Certain Reserve Samples
By:
on
NOV
06
Audience: Health Care Professional, Pharmacy November 6,2025 – LAKE ZURICH, Ill.— Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies is voluntarily...
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NOV
05
FDA Warns Companies Over Illegal Marketing of Botox and Related Products
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on
NOV
05
Audience: Health Care Professional, Consumer November 05, 2025 -- The U.S. Food and Drug Administration issued 18 warning letters to owners of websites illegally marketing unapproved and misbranded botulinum toxin products, commonly called Botox...
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OCT
31
FDA Acts to Protect Children from Unapproved Fluoride Drug Products
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on
OCT
31
Audience: Health Care Professionals The U.S. Food and Drug Administration today announced actions to restrict the sale of unapproved ingestible fluoride prescription drug products for children. The FDA sent notices to four companies outlining the...
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OCT
31
Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection
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on
OCT
31
Audience: Health Care Professional, Pharmacy October 31, 2025 AUSTIN, TX – Otsuka ICU Medical LLC is issuing a voluntary recall to the user level, for a MISLABELLED lot of POTASSIUM CHLORIDE Inj. 20 mEq, NDC 0990-7077-14. The OVERWRAP label of...
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