Mericon Industries, Inc. – 692733 – 07/17/2025
Unapproved New Drugs/Misbranded
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Columbia Cosmetics Manufacturing Inc. – 710885 – 09/11/2025
CGMP/Finished Pharmaceuticals/Adulterated -
Blue Forest Farms, LLC – 711990 – 09/11/2025
Adulterated Human Foods/Misbranded -
CSL Behring – 716297 – 09/09/2025
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) -
Investigational New Drug (IND) Application
Get to know the investigational new drug application (IND). This includes the types, laws and regulations, and emergency use of INDs. -
Lupin Limited Unit 2 – 7/17/2025
Lupin Limited Unit 2 – 7/17/2025. Country: India. Record Type: 483 -
Looking to our future: reflections on the strategic choices ahead for the MHRA
As part of developing its new five-year strategy, the MHRA is publishing a series of blogs on the challenges and opportunities ahead. In the first instalment, Chief Executive Lawrence Tallon reflects on the changing healthcare landscape, the regulator’s role, and the priorities shaping the agency’s future direction.
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Vorasidenib approved to treat patients 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 16th September 2025, approved the medicine vorasidenib (Voranigo).
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BD Provides Update on Voluntary Recall of Certain BD Alaris™ Pump Infusion Sets
FRANKLIN LAKES, N.J. (Sept. 12, 2025) – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today expanded their Class I voluntary recall initiated in the United States on July 8, 2025 and expanded on July 17, 2025 to inform customers of worst-case performanc -
Ventilator Recall: Philips Respironics Removes Certain DreamStation Devices Due to Programming Errors That Can Result in Failed Therapy Modes
DreamStation devices may deliver incorrect therapy due to programming errors. Continued use could cause ineffective treatment or harm. -
Influenza (Flu) Antiviral Drugs and Related Information
Flu is a serious disease, caused by influenza viruses, that can lead to hospitalization and even death. Your best defense is vaccination, which provides important protection from flu and its potential complications. -
Update on Alert: Defibrillation Lead Issue from Boston Scientific
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.