FDA daily for Tuesday, February 3, 2026
In this issue: 17 approvals, 12 device recalls, 13 device decisions and 180 label changes. 2 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.
- Acne Moisturizer
SALICYLIC ACID · Spa de Soleil · TOPICAL
- SPF 50 Mineral Sunscreen Kids
ZINC OXIDE 14.69% · S&C Hampton Sun LLC · TOPICAL
Drug and biologic approvals
FDA date:On Tue, Jan 27 FDA approved 5 new applications (0 brand or biologic, 5 generic) and 12 supplements to existing ones.
- MESNA
EUGIA PHARMA · MESNA
- DEFLAZACORT
SUN PHARM INDS INC · DEFLAZACORT
- PROPRANOLOL HYDROCHLORIDE
MANKIND PHARMA · PROPRANOLOL HYDROCHLORIDE
- TAPENTADOL HYDROCHLORIDE
EPIC PHARMA LLC · TAPENTADOL HYDROCHLORIDE
- FIDAXOMICIN
TORRENT · FIDAXOMICIN
Device recalls
FDA date:FDA posted 12 device recalls from 4 firms on Tue, Jan 27.
- Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
Siemens Medical Solutions USA, Inc · Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previ…
- Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02
Siemens Medical Solutions USA, Inc · Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previ…
- Alphenix INFX-8000C, interventional fluoroscopic x-ray system
Canon Medical System, USA, INC. · It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray…
- Alphenix INFX-8000F, interventional fluoroscopic x-ray system
Canon Medical System, USA, INC. · It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray…
- Alphenix INFX-8000H, interventional fluoroscopic x-ray system
Canon Medical System, USA, INC. · It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray…
- Alphenix INFX-8000V, interventional fluoroscopic x-ray system
Canon Medical System, USA, INC. · It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray…
- Bandages and first aid kits: FIRST AID KIT 24/42PC, LUCKY FIRST AID BANDAGES 24CT
GOLD STAR DISTRIBUTION INC · Potential exposure of rodents and rodent activity in the distribution center.
- Condoms, labeled as: TROJAN MAGNUM CONDOMS 6/DSP BLACK, TROJAN LUBRICATED CONDOMS 6/DSP LITE BLUE, TROJAN SPERMICIDE CONDOMS 6/DSP DARK BLU…
GOLD STAR DISTRIBUTION INC · Potential exposure of rodents and rodent activity in the distribution center.
- Feminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT, ALWAYS THIN LINERS UNSCENTED 12 CT, ALWAYS THIN LINERS SCENTED 12C…
GOLD STAR DISTRIBUTION INC · Potential exposure of rodents and rodent activity in the distribution center.
- Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE TOOTH BRUSH MED. 12CT; ADULT TOOTHPASTE W BRUSH (WHITENING) 6.4…
GOLD STAR DISTRIBUTION INC · Potential exposure of rodents and rodent activity in the distribution center.
- PREGNANCY TEST 24CT
GOLD STAR DISTRIBUTION INC · Potential exposure of rodents and rodent activity in the distribution center.
- Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041 Conductivity Standard Solutions…
NIPRO Technical Services, Inc. · due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect conductivity values f…
Device clearances and approvals
FDA date:FDA decided 9 510(k)s and 4 PMA decisions on Tue, Jan 20.
- uCT 780 with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare Co., Ltd. · Radiology
- Excelsior System
Blue Ocean Global · Orthopedic
- DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector
Carestream Health · Radiology
- Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)
Scivita Medical Technology Co., Ltd. · Gastroenterology, Urology
- Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes
Cooper Surgical · Obstetrics/Gynecology
- Clearview Intracoronary Shunts
Medtronic, Inc. · Cardiovascular
- VariFuse Adjustable Infusion Catheter
Argon Medical Devices, Inc. · Cardiovascular
- Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System
Canon Medical Systems Corporation · Radiology
- Rusch SoftSimplastic Foley Catheters
Teleflex Medical Sdn. Bhd. · Gastroenterology, Urology
Label updates
FDA date:180 drug labels took effect on Tue, Jan 20; 5 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Acne Moisturizer
SALICYLIC ACID · Spa de Soleil · TOPICAL
- SPF 50 Mineral Sunscreen Kids
ZINC OXIDE 14.69% · S&C Hampton Sun LLC · TOPICAL
- Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four
ZINC OXIDE · Clean Beauty For All, Inc (dba Saie) · TOPICAL
- Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Five and Half
ZINC OXIDE · Clean Beauty For All, Inc (dba Saie) · TOPICAL
- Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Three and Half
ZINC OXIDE · Clean Beauty For All, Inc (dba Saie) · TOPICAL
- Olmesartan Medoxomil
OLMESARTAN MEDOXOMIL · A-S Medication Solutions · ORAL
- Sertraline Hydrochloride
SERTRALINE HYDROCHLORIDE · Dr. Reddy's Laboratories Inc. · ORAL
- Bupropion hydrochloride
BUPROPION HYDROCHLORIDE · Preferred Pharmaceuticals Inc. · ORAL
- Diazepam
DIAZEPAM · Direct_Rx · 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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