FDA daily for Thursday, November 12, 2026
In this issue: 9 approvals, 2 device recalls, 38 device decisions and 231 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.
- Note BB 500
OCTINOXATE · ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI · TOPICAL
- Note BB 200 Soft Ivory
OCTINOXATE · ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI · TOPICAL
Drug and biologic approvals
FDA date:On Thu, Nov 5 FDA approved 2 new applications (0 brand or biologic, 2 generic) and 7 supplements to existing ones.
- ELTROMBOPAG OLAMINE
CHANGZHOU PHARM · ELTROMBOPAG OLAMINE
- AMITRIPTYLINE HYDROCHLORIDE
CMP DEV LLC · AMITRIPTYLINE HYDROCHLORIDE
Device recalls
FDA date:FDA posted 2 device recalls from 2 firms on Thu, Nov 5.
- Halyard ARTHROSCOPY PACK. Model/Catalog Number: SAMM014-21.
AVID Medical, Inc. · Shelf label of kit is mislabeled as "Extremity" instead of "Arthroscopy Pack."
- LIAISON PLEX Gram-Negative Blood Culture Assay Catalog No. 20-005-303
Luminex Corporation · Instructions for Use updated to include explicit guidance that repeat testing is recommended whenever a positive family-level only result is obtained. Issue ma…
Device clearances and approvals
FDA date:FDA decided 25 510(k)s and 13 PMA decisions on Thu, Oct 29.
- KeriFlex® MCP and PIP Finger Joint Prostheses
Keri Medical SA · Orthopedic
- Symmetrix PX Spinal System
Medtronic Sofamor Danek USA, Inc. · Orthopedic
- Libertas Acetabular Liners (Acetabular Liner)
Maxx Orthopedics, Inc. · Orthopedic
- Minder® System
Epi-Minder Pty, Ltd. · Neurology
- Vitrea Advanced Visualization, Version 7.16
Canon Medical Informatics, Inc. · Radiology
- ELEOS Limb Salvage System with NanoCept® Technology (Proximal Tibia) (AM-25002200-C)
Onkos Surgical, Inc. · Orthopedic
- Virata Spinal Fixation System
SeaSpine Orthopedics Corporation · Orthopedic
- OSSIX Plus
Datum Dental, Ltd. · Dental
- Cerclage Cabling System
Pioneer Surgical Technology, Inc. dba EXALTA Group · Orthopedic
- V-Pro maX 2 Low Temperature Sterilization System
STERIS · General Hospital
- SEEG-Tx® System (STX-SYS-001)
Dixi Medical · Neurology
- Zirconia Dental Ceramics and Staining Solution
Fanen New Materials Technology (Suzhou) Co., Ltd. · Dental
- VasQ
Laminate Medical Technologies · Cardiovascular
- SWICS
Bloom Surgical, Inc. · Gastroenterology, Urology
- Cleerly ISCHEMIA
Cleerly, Inc. · Cardiovascular
Label updates
FDA date:231 drug labels took effect on Thu, Oct 29; 7 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Note BB 500
OCTINOXATE · ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI · TOPICAL
- Note BB 200 Soft Ivory
OCTINOXATE · ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI · TOPICAL
- Note Mattifying Extreme Wear Foundation 110 Smoke
OCTINOXATE · ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI · TOPICAL
- Thrive Daily Defense Sunscreen Balm SPF30
ZINC OXIDE · Thrive Natural Care, Inc · TOPICAL
- Thrive Daily Sunscreen For Sensitive Skin SPF 30
ZINC OXIDE · Thrive Natural Care, Inc · TOPICAL
- Thrive Bodyshield 50 SPF 50
ZINC OXIDE · Thrive Natural Care, Inc · TOPICAL
- Note BB Advanced Skin Corrector SPF 15, 02
OCTINOXATE · ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI · TOPICAL
- Lorazepam
LORAZEPAM · SUN PHARMACEUTICAL INDUSTRIES INC · ORAL
- Methotrexate
METHOTREXATE · Hospira, Inc. · INTRAMUSCULAR, INTRAVENOUS +2
- Sertraline Hydrochloride
SERTRALINE HYDROCHLORIDE · PD-Rx Pharmaceuticals, Inc. · ORAL
FDA did not answer for Drug shortages, Food and supplement recalls, Drug recalls while this issue was written; those sections will fill in on a later visit.
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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