FDA daily for Monday, March 10, 2025
In this issue: 22 approvals, 12 device recalls, 14 device decisions and 60 label changes. 5 items touch categories MedGrid carries, and they come first.
For MedGrid's categories
Items in this issue that name a product category sold on MedGrid. Each links to its full FDA record; the chip opens that category's federal and state rules.
- TRETINOIN
ENCUBE · TRETINOIN
- TRETINOIN
ENCUBE · TRETINOIN
- Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs
Lingshi Hongruida Health Protection Technology Co., Ltd. · General Hospital
Drug and biologic approvals
FDA date:On Mon, Mar 3 FDA approved 12 new applications (1 brand or biologic, 11 generic) and 10 supplements to existing ones.
- TRETINOIN
ENCUBE · TRETINOIN
- TRETINOIN
ENCUBE · TRETINOIN
- TEVIMBRA
BEIGENE · islelizumab-jsgr
- DASATINIB
BIOCON PHARMA · DASATINIB
- OXAZEPAM
LEADING · OXAZEPAM
- DASATINIB
ZYDUS PHARMS · DASATINIB
- LENALIDOMIDE
BIOCON PHARMA · LENALIDOMIDE
- OSELTAMIVIR PHOSPHATE
JUBILANT GENERICS · OSELTAMIVIR PHOSPHATE
- DASATINIB
DR REDDYS · DASATINIB
- RIVAROXABAN
LUPIN · RIVAROXABAN
- RIVAROXABAN
TARO · RIVAROXABAN
- TELMISARTAN AND HYDROCHLOROTHIAZIDE
MANKIND PHARMA · HYDROCHLOROTHIAZIDE, TELMISARTAN
Device recalls
FDA date:FDA posted 12 device recalls from 1 firm on Mon, Mar 3.
- Paradigm REF: MMT-712 and MMT-715
Medtronic MiniMed, Inc. · All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to c…
- Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
Medtronic MiniMed, Inc. · All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to c…
- Paradigm insulin pump, REF: MMT-754
Medtronic MiniMed, Inc. · All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to c…
- MiniMed insulin pump, REF: 620G (MMT-1750)
Medtronic MiniMed, Inc. · All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to c…
- MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
Medtronic MiniMed, Inc. · All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to c…
- MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
Medtronic MiniMed, Inc. · All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to c…
- MiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
Medtronic MiniMed, Inc. · All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to c…
- MiniMed insulin pump, REF: 700G (MMT-1801, MMT-1805, MMT-1850, MMT-1851)
Medtronic MiniMed, Inc. · All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to c…
- MiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
Medtronic MiniMed, Inc. · All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to c…
- MiniMed insulin pump, REF: 740G (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
Medtronic MiniMed, Inc. · All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to c…
- MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
Medtronic MiniMed, Inc. · All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to c…
- MiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
Medtronic MiniMed, Inc. · All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to c…
Device clearances and approvals
FDA date:FDA decided 8 510(k)s and 6 PMA decisions on Mon, Feb 24.
- Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs
Lingshi Hongruida Health Protection Technology Co., Ltd. · General Hospital
- Control-IQ+ technology
Tandem Diabetes Care, Inc. · Clinical Chemistry
- Ulthera® System
Ulthera, Inc. · General, Plastic Surgery
- OncoStudio (OS-01)
Oncosoft. Co., Ltd. · Radiology
- ExamVue Apex
Jpi Healthcare Co, Ltd. · Radiology
- Sterilization Package/Reel
Anqing Clean Dental Instrument Technology Co., Ltd. · General Hospital
- SD Implant System
Arum Dentistry Co., Ltd. · Dental
- APRO 70 Swift Catheter and Alembic Aspiration Tubing
Alembic, LLC · Cardiovascular
Label updates
FDA date:60 drug labels took effect on Mon, Feb 24; 3 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Sun Defense Minerals (Tan)
ZINC OXIDE, TITANIUM DIOXIDE · Eminence Organic Skin Care · TOPICAL
- Ciprofloxacin
CIPROFLOXACIN HYDROCHLORIDE · Golden State Medical Supply, Inc. · ORAL
- Diclofenac Potassium
DICLOFENAC POTASSIUM · Coupler LLC · ORAL
How the FDA daily is written
Every issue is written from FDA's public data (openFDA) and nothing else: the counts, names, firms and reasons are FDA's own. openFDA posts each kind of record on its own delay, so each section covers one FDA date and says which. Shortages cover yesterday; approvals, drug and device recalls, and food and supplement recalls cover a week ago; device clearances and label changes cover two weeks ago. Every FDA date appears in exactly one issue. Complete response letters appear the day after FDA publishes a batch.
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