FDA daily for Monday, April 7, 2025
In this issue: 90 approvals, 10 device recalls, 16 device decisions and 54 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.
- DOMINAS DARK SPOT TINTED SUNSCREEN
OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE · LG H&H CO., LTD. · TOPICAL
Drug and biologic approvals
FDA date:On Mon, Mar 31 FDA approved 3 new applications (0 brand or biologic, 3 generic) and 87 supplements to existing ones.
- PANTOPRAZOLE SODIUM
AUROBINDO PHARMA LTD · PANTOPRAZOLE SODIUM
- PANTOPRAZOLE SODIUM
CIPLA · PANTOPRAZOLE SODIUM
- PANTOPRAZOLE SODIUM
ALEMBIC · PANTOPRAZOLE SODIUM
Device recalls
FDA date:FDA posted 10 device recalls from 5 firms on Mon, Mar 31.
- Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.
Stryker Spine · Potential for the gold unlock button to separate from the inserter.
- Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
Stryker Spine · Potential for the gold unlock button to separate from the inserter.
- Monterey AL Implant Inserter; 18/20mm; Catalog 48019130.
Stryker Spine · Potential for the gold unlock button to separate from the inserter.
- Monterey AL Implant Inserter; 22mm; Catalog 48019140.
Stryker Spine · Potential for the gold unlock button to separate from the inserter.
- Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Terumo Cardiovascular Systems Corporation · During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. I…
- Phoroptor VRx Digital Refraction System Model Numbers: 16241
Reichert, Inc. · The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
- Phoroptor VRx Digital Refraction System Model Numbers: 16242
Reichert, Inc. · The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
- Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.
Fisher Diagnostics · The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
- Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
Fisher Diagnostics · The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
- Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
Qiagen Sciences LLC · Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
Device clearances and approvals
FDA date:FDA decided 13 510(k)s and 3 PMA decisions on Mon, Mar 24.
- Alinity m BKV
Abbott Molecular, Inc. · Microbiology
- Innovasis Navigation Instruments
Innovasis, Inc. · Neurology
- UltraCor Twirl Breast Tissue Marker
Bard Peripheral Vascular, Inc. · General, Plastic Surgery
- VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System
Luma Vision Limited · Cardiovascular
- VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP)
Control Medical Technology, Inc. / Dba Ventiv Scientific · Cardiovascular
- Klassic Knee System - Revision Tibial Baseplate
Total Joint Othopedics, Inc. · Orthopedic
- SonoTAP and SonoTAP II
PAJUNK GmbH Medizintechnologie · Anesthesiology
- AERO MIS Facet Fusion System
Aurora Spine · Unknown
- LMNT O2
Xplr , Ltd. · General, Plastic Surgery
- TIDAL Fusion Cage System
Restor3D, Inc. · Orthopedic
- AxTiHA® Stand-Alone ALIF System
Innovasis · Orthopedic
- Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
Stryker Instruments · Unknown
Label updates
FDA date:54 drug labels took effect on Mon, Mar 24; 11 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- DOMINAS DARK SPOT TINTED SUNSCREEN
OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE · LG H&H CO., LTD. · TOPICAL
- KISS New York Tinted Moisturizer
ZINC OXIDE · IVY ENTERPRISES, INC. · TOPICAL
- KISS New York Tinted Moisturizer
ZINC OXIDE · IVY ENTERPRISES, INC. · TOPICAL
- KISS New York Tinted Moisturizer
ZINC OXIDE · IVY ENTERPRISES, INC. · TOPICAL
- KISS New York Tinted Moisturizer
ZINC OXIDE · IVY ENTERPRISES, INC. · TOPICAL
- KISS New York Tinted Moisturizer
ZINC OXIDE · IVY ENTERPRISES, INC. · TOPICAL
- KISS New York Tinted Moisturizer
ZINC OXIDE · IVY ENTERPRISES, INC. · TOPICAL
- Walgreens SPF 50 Clear Complexion Face Sunscreen
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE · WALGREEN COMPANY · TOPICAL
- CVS Health SPF 70 Ultra Sheer
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE · CVS Pharmacy · TOPICAL
- CVS Health SPF 70 Beach Guard Clear
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE · CVS Pharmacy · TOPICAL
- Oxycodone HCL
OXYCODONE HCL · 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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