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FDA Daily

FDA daily for Friday, September 11, 2026

159 FDA records across 4 sections. 9 touch MedGrid's categories and are listed first.

159FDA Records
4 of 7Sections With Data
9Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Thu, Sep 10 (yesterday)
1
  • Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride Solution

    DELFLEX, Solution, 18.4 mg/100 mL; 4.25 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 46163-212-95) — Fresenius Medical Care North America

    New · To Be Discontinued · Renal

Drug approvalsCovers FDA's Fri, Sep 4 (a week ago)
6
  • NITROFURANTOIN

    NITROFURANTOIN — NOVITIUM PHARMA

    ANDA216385 · Labeling

  • LACOSAMIDE

    LACOSAMIDE — REGCON HOLDINGS

    ANDA208308 · Manufacturing (CMC)

  • DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

    DEXTROMETHORPHAN HYDROBROMIDE, QUINIDINE SULFATE — ACTAVIS ELIZABETH

    ANDA202934 · Manufacturing (CMC)

  • ETCAMAH

    CAMIZESTRANT — ASTRAZENECA

    NDA220359 · Original approval

  • MINOXIDIL (FOR MEN)

    MINOXIDIL — TARO

    ANDA209074 · Labeling

  • TOPIRAMATE

    TOPIRAMATE — MICRO LABS

    ANDA219183 · Original approval

Drug recallsCovers FDA's Fri, Sep 4 (a week ago)
Nothing from FDA for this date
Food and supplement recallsCovers FDA's Fri, Sep 4 (a week ago)
Nothing from FDA for this date
Device recallsCovers FDA's Fri, Sep 4 (a week ago)
Nothing from FDA for this date
Device clearancesCovers FDA's Fri, Aug 28 (two weeks ago)
16
  • LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)

    Medtronic, Inc.

    K262735 · Substantially Equivalent · Cardiovascular

  • X-Guide Surgical Navigation System

    X-Nav Technologies, LLC

    K253954 · Substantially Equivalent · Dental

  • Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)

    Zhengzhou PZ Laser Slim Technology Co., Ltd.

    K261582 · Substantially Equivalent · General, Plastic Surgery

  • Kiba CTO Crossing Catheter

    Reflow Medical, Inc.

    K262013 · Substantially Equivalent · Cardiovascular

  • Carescape Canvas 1000; Carescape Canvas Smart Display

    GE Healthcare Finland Oy

    K260343 · Substantially Equivalent · Cardiovascular

  • Mpact 3D Metal Foam

    Medacta International S.A.

    K253630 · Substantially Equivalent · Orthopedic

  • Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)

    CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.

    K254261 · Substantially Equivalent · Obstetrics/Gynecology

  • Automatic Core Biopsy Instrument

    Zhejiang Curaway Medical Technology Co., Ltd.

    K260517 · Substantially Equivalent · Gastroenterology, Urology

  • Primal K-Wire (P99-193-1410)

    Paragon 28, Inc.

    K262722 · Substantially Equivalent · Orthopedic

  • FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate Sy…

    Ortler Global Tibbi Gerecler Anonim Sirketi

    K261830 · Substantially Equivalent · Orthopedic

  • Rayvolve AZchest

    AZmed

    K261378 · Substantially Equivalent · Radiology

  • Tigertriever 13 Ultra Revascularization Device

    Rapid Medical Ltd.

    K260617 · Substantially Equivalent · Cardiovascular

Showing 12 of 16. Search the rest in openFDA.

Label changesCovers FDA's Fri, Aug 28 (two weeks ago)
9 touch MedGrid136
  • Olu Pain ManagementTouches MedGrid categories

    HAWAII REPACK, INC.

    Label version 2

  • LidocaineTouches MedGrid categories

    A-S Medication Solutions

    Label version 1

  • ZepboundTouches MedGrid categories

    Eli Lilly and Company

    Label version 40

  • Hello Bello Mineral Sunscreen SPF 50Touches MedGrid categories

    Topiderm, Inc.

    Label version 1

  • Utu Broad Spectrum SPF 30 Moisturizing Face Mineral Zinc Oxide Sunscreen UnscentedTouches MedGrid categories

    Utu Co

    Label version 2

  • Utu Broad Spectrum SPF 30 Moisturizing Body SunscreenTouches MedGrid categories

    Utu Co

    Label version 2

  • 4% Lidocaine PatchesTouches MedGrid categories

    Shenzhen Chaoxiji Technology Co.,Ltd.

    Label version 1

  • Relieved Pro WrapTouches MedGrid categories

    Transfer Technology

    Label version 1

  • PROGESTERONETouches MedGrid categories

    REMEDYREPACK INC.

    Label version 4

  • Tetracaine Hydrochloride

    REMEDYREPACK INC.

    Label version 3

  • OP Triple Antibiotic

    Yiwu Ori-Power Medtech Co., Ltd.

    Label version 3

  • Ketorolac Tromethamine

    REMEDYREPACK INC.

    Label version 6

Showing 12 of 136. Search the rest in openFDA.

How the FDA Daily Is WrittenSources, dates and what gets flagged

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 recalls, 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. Items that touch the categories MedGrid works in, such as GLP-1s, hormones, injectables, peptides, compounded products and aesthetic devices, are marked and listed first.

Subscribe with any feed reader, or point an email tool at theRSS feed. For the rules behind the headlines, see Regulations Research.

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.