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FDA Daily

FDA daily for Tuesday, August 4, 2026

258 FDA records across 4 sections. 5 touch MedGrid's categories and are listed first.

258FDA Records
4 of 7Sections With Data
5Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Mon, Aug 3 (yesterday)
18
  • Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Intraperitoneal Injection, Solution

    DIANEAL PD-2 with Dextrose, Intraperitoneal Injection, Solution, 25.7 mg/100 mL; 4.25 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 0941-0429-53) — Vantive US Healthcare LLC

    New · To Be Discontinued · Renal

  • Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Intraperitoneal Injection, Solution

    DIANEAL Low Calcium with Dextrose, Intraperitoneal Injection, Solution, 18.3 mg/100 mL; 2.5 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 0941-0430-51) — Vantive US Healthcare LLC

    New · To Be Discontinued · Renal

  • Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Intraperitoneal Injection, Solution

    DIANEAL Low Calcium with Dextrose, Intraperitoneal Injection, Solution, 18.3 mg/100 mL; 4.25 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 0941-0433-51) — Vantive US Healthcare LLC

    New · To Be Discontinued · Renal

  • Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Intraperitoneal Injection, Solution

    DIANEAL PD-2 with Dextrose, Intraperitoneal Injection, Solution, 25.7 mg/100 mL; 4.25 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 0941-0415-07) — Vantive US Healthcare LLC

    New · To Be Discontinued · Renal

  • Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Intraperitoneal Injection, Solution

    DIANEAL PD-2 with Dextrose, Intraperitoneal Injection, Solution, 25.7 mg/100 mL; 1.5 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 0941-0426-52) — Vantive US Healthcare LLC

    New · To Be Discontinued · Renal

  • Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Intraperitoneal Injection, Solution

    DIANEAL PD-2 with Dextrose, Intraperitoneal Injection, Solution, 25.7 mg/100 mL; 4.25 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 0941-0415-06) — Vantive US Healthcare LLC

    New · To Be Discontinued · Renal

  • Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Intraperitoneal Injection, Solution

    DIANEAL Low Calcium with Dextrose, Intraperitoneal Injection, Solution, 18.3 mg/100 mL; 1.5 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 0941-0424-51) — Vantive US Healthcare LLC

    New · To Be Discontinued · Renal

  • Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Intraperitoneal Injection, Solution

    DIANEAL PD-2 with Dextrose, Intraperitoneal Injection, Solution, 25.7 mg/100 mL; 4.25 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 0941-0429-52) — Vantive US Healthcare LLC

    New · To Be Discontinued · Renal

  • Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Intraperitoneal Injection, Solution

    DIANEAL Low Calcium with Dextrose, Intraperitoneal Injection, Solution, 18.3 mg/100 mL; 4.25 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 0941-0459-05) — Vantive US Healthcare LLC

    New · To Be Discontinued · Renal

  • Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Intraperitoneal Injection, Solution

    DIANEAL PD-2 with Dextrose, Intraperitoneal Injection, Solution, 25.7 mg/100 mL; 2.5 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 0941-0427-52) — Vantive US Healthcare LLC

    New · To Be Discontinued · Renal

  • Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Intraperitoneal Injection, Solution

    DIANEAL Low Calcium with Dextrose, Intraperitoneal Injection, Solution, 18.3 mg/100 mL; 1.5 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 0941-0409-07) — Vantive US Healthcare LLC

    New · To Be Discontinued · Renal

  • Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Intraperitoneal Injection, Solution

    DIANEAL PD-2 with Dextrose, Intraperitoneal Injection, Solution, 25.7 mg/100 mL; 1.5 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 0941-0411-06) — Vantive US Healthcare LLC

    New · To Be Discontinued · Renal

Showing 12 of 18. Search the rest in openFDA.

Drug approvalsCovers FDA's Tue, Jul 28 (a week ago)
1 touch MedGrid23
  • GWYN LOTouches MedGrid categories

    ETHINYL ESTRADIOL, NORELGESTROMIN — VIATRIS SPECIALTY

    NDA219990 · Original approval

  • SUGAMMADEX SODIUM

    SUGAMMADEX SODIUM — HIKMA

    ANDA218727 · Original approval

  • LINEZOLID

    LINEZOLID — ZYDUS PHARMS

    ANDA206097 · Labeling

  • SUGAMMADEX SODIUM

    SUGAMMADEX SODIUM — TAMARANG

    ANDA215260 · Original approval

  • GLYCEROL PHENYLBUTYRATE

    GLYCEROL PHENYLBUTYRATE — PAI HOLDINGS

    ANDA220579 · Original approval

  • GADAVIST

    GADOBUTROL — BAYER HLTHCARE

    NDA201277 · Labeling

  • SUGAMMADEX SODIUM

    SUGAMMADEX SODIUM — TEVA PHARMS USA INC

    ANDA214126 · Original approval

  • DIAZEPAM

    DIAZEPAM — BAXTER HLTHCARE CORP

    ANDA219882 · Original approval

  • SUGAMMADEX SODIUM

    SUGAMMADEX SODIUM — STERISCIENCE

    ANDA218814 · Original approval

  • SUGAMMADEX SODIUM

    SUGAMMADEX SODIUM — MANKIND PHARMA

    ANDA214230 · Original approval

  • SUGAMMADEX SODIUM

    SUGAMMADEX SODIUM — DR REDDYS

    ANDA214236 · Original approval

  • TRAMADOL HYDROCHLORIDE

    TRAMADOL HYDROCHLORIDE — GRAVITI PHARMS

    ANDA075968 · Manufacturing (CMC)

Showing 12 of 23. Search the rest in openFDA.

Drug recallsCovers FDA's Tue, Jul 28 (a week ago)
Nothing from FDA for this date
Food and supplement recallsCovers FDA's Tue, Jul 28 (a week ago)
Nothing from FDA for this date
Device recallsCovers FDA's Tue, Jul 28 (a week ago)
Nothing from FDA for this date
Device clearancesCovers FDA's Tue, Jul 21 (two weeks ago)
1 touch MedGrid10
  • Medical Thulium Fiber Laser Systems (UroFiber 150Q)Touches MedGrid categories

    Rhein Laser Technologies Co., Ltd.

    K261738 · Substantially Equivalent · General, Plastic Surgery

  • Versalock Proximal Tibial Plating System

    GM Dos Reis Industria e Comercio Ltda.

    K261406 · Substantially Equivalent · Orthopedic

  • Raney Clips Kit

    Beijing Honghugaoxiang Science and Technology Development CO

    K253814 · Substantially Equivalent · Neurology

  • ResolutionMD

    ResolutionMD, Inc.

    K260500 · Substantially Equivalent · Radiology

  • OTTAVA™ Robotic Surgical System

    Auris Health, Inc., part of Johnson & Johnson MedTech

    DEN250068 · Unknown · General, Plastic Surgery

  • Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)

    Xuzhou Kernel Medical Equipment Co., Ltd.

    K261775 · Substantially Equivalent · Unknown

  • One-Fil LC

    Mediclus Co., Ltd.

    K261728 · Substantially Equivalent · Dental

  • PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves

    O&M Halyard, Inc.

    K262014 · Substantially Equivalent · General Hospital

  • NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus…

    Hycor Biomedical

    K260591 · Substantially Equivalent · Immunology

  • CardIQ Suite

    GE Medical Systems SCS

    K253770 · Substantially Equivalent · Radiology

Label changesCovers FDA's Tue, Jul 21 (two weeks ago)
3 touch MedGrid207
  • SYLVIRENE NUMBINGTouches MedGrid categories

    Jiangxi Yudexi Pharmaceutical Co., LTD

    Label version 2

  • REINREUDE PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAINTouches MedGrid categories

    Jiangxi Yudexi Pharmaceutical Co., LTD

    Label version 2

  • EstradiolTouches MedGrid categories

    Redpharm Drug

    Label version 1

  • Drug label

    Label version 4

  • BICILLIN L-A

    Pfizer Laboratories Div Pfizer Inc

    Label version 35

  • Drug label

    Label version 2

  • capecitabine

    NorthStar RxLLC

    Label version 2

  • Aveeno Soothing Bath Treatment

    Kenvue Brands LLC

    Label version 9

  • Lyfgenia

    Genetix Biotherapeutics Inc.

    Label version 8

  • Methocarbamol

    PD-Rx Pharmaceuticals, Inc.

    Label version 9

  • Lisinopril

    Aurobindo Pharma Limited

    Label version 27

  • Amoxicillin

    REMEDYREPACK INC.

    Label version 21

Showing 12 of 207. 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.

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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.