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🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Furosemide

Official structured record identifier: 58d2a38d-75f8-dcb9-e063-6294a90a10d7.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Antiseptic

Official structured record identifier: 584b38ce-d1ef-4ecc-a887-7c96e7f9669f.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: CVS PHARMACY Childrens Allergy Chews

Official structured record identifier: 569b8efa-8458-49f7-a665-6b7016a10505.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Gemachlich Zu Hause Vaginal Antifungal Gel

Official structured record identifier: 563cfb57-f10c-96a6-e063-6294a90a2b93.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Azithromycin monohydrate

Official structured record identifier: 55051e03-b6dc-4bc6-87c1-e4fb84b61fa3.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: NumbMD Lidocaine Cream Anorectal(hemorrhoidal)

Official structured record identifier: 52379055-d017-4d98-e063-6294a90a196c.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Nupharmisto NumbMD Lidocaine Cream

Official structured record identifier: 52369a41-820d-cd7a-e063-6394a90ac6d1.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Isibloom

Official structured record identifier: 4a8f278f-f505-4537-8deb-74e8927df8c6.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: CVS Health Extra Strength Sugar Free

Official structured record identifier: 49e23561-d392-415c-9e6f-2dbcf64c9636.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Gembooxt Topical Numbing Cream

Official structured record identifier: 49951a3e-3b62-3d66-e063-6294a90a9360.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Nupharmisto NumbMD LIDOCAINE cream anorectal (hemorrhoidal)

Official structured record identifier: 483d81a3-7493-3391-e063-6394a90a2e3d.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Carbamazepine

Official structured record identifier: 48080efd-1781-4585-83f8-c43957ac63b3.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Spot Correction

Official structured record identifier: 45ec40ff-7134-085b-e054-00144ff8d46c.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Arthritis Pain Reliever

Official structured record identifier: 4484a332-aab1-46a9-aca8-159e7a09439f.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Treatonic hemorrhoid treatment

Official structured record identifier: 41442fa7-c511-07ca-e063-6294a90a3992.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Numbing Cream

Official structured record identifier: 35b5ba9d-da1d-55d6-e063-6294a90a5fa8.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: divalproex sodium

Official structured record identifier: 352b4c3c-e419-4827-9e00-febb0164e0f5.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Diclofenac sodium

Official structured record identifier: 2a7019e9-e20f-4897-9b8e-942a7f2b34f6.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Mini Nicotine

Official structured record identifier: 286e2768-ad98-43be-a3be-a2db0370f50f.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Naproxen Sodium

Official structured record identifier: 27938b08-ff37-4587-aa81-5ec3ef21a28a.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: UV Skin Recovery SPF 50 Red Correcting

Official structured record identifier: 26e63890-d1af-d171-e063-6394a90af828.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: UV Skin Recovery SPF 50

Official structured record identifier: 26d2683f-cfd5-50fd-e063-6394a90a7576.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Gencare- Pain Relief Acetaminophen

Official structured record identifier: 2111c91b-2fd7-4ab3-946a-d4e0cf46399a.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Pain Reliever Extra Strength

Official structured record identifier: 1dbd8480-5cb4-4577-9091-b2a2add4f1af.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Stomach Relief Regular Strength

Official structured record identifier: 1af2a7dd-45d7-41a0-af61-4a588f1c1985.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Midazolam

Official structured record identifier: 1abda8b8-48a8-4995-af86-39220d1aa240.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: CVS PHARMACY,INC. Assorted Berry

Official structured record identifier: 19f0847e-1512-465c-b67f-d61ef4a16cfa.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: PLUVICTO

Official structured record identifier: 14908037-2892-4d98-a053-253ce35afb1a.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: 24 PK BLEMISH DOT

Official structured record identifier: 13b5a729-e265-47fd-b082-2557805d08bc.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Miconazole 7

Official structured record identifier: 0cef9212-201d-4fd2-8afb-ae06ea6b6ee4.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: unspecified product

Official structured record identifier: 07e7444f-4b72-46b4-a4bb-af2d90ffa933.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: ZITUVIMET

Official structured record identifier: 0098dec4-f0e5-45d5-8aa4-5d0faf9ab142.

openFDA Drug LabelsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: MIRABEGRON

Official structured record identifier: 99563.

openFDA Drug RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Inc., Atlanta, 1750 Corp Dr. Ste 725, Norcross, GA 30093 (844) 903-6418

Official structured record identifier: 99535.

openFDA Drug RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: DICYCLOMINE HYDROCHLORIDE

Official structured record identifier: 99492.

openFDA Drug RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8114-1

Official structured record identifier: 99437.

openFDA Drug RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system

Official structured record identifier: 99475.

openFDA Device RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph

Official structured record identifier: 99400.

openFDA Device RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Merge PACS, medical imaging diagnostic workstation

Official structured record identifier: 99391.

openFDA Device RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic

Official structured record identifier: 99389.

openFDA Device RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL

Official structured record identifier: 99381.

openFDA Device RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000

Official structured record identifier: 99365.

openFDA Device RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instr

Official structured record identifier: 99349.

openFDA Device RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm

Official structured record identifier: 99346.

openFDA Device RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No

Official structured record identifier: 99345.

openFDA Device RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905

Official structured record identifier: 99344.

openFDA Device RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640

Official structured record identifier: 99340.

openFDA Device RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15

Official structured record identifier: 99339.

openFDA Device RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System

Official structured record identifier: 99328.

openFDA Device RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11

Official structured record identifier: 99307.

openFDA Device RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version: WebApp version 2.33.1, 2.33.3 and 2.34.2 Product Description: WASPLab is an automated device intended to be used for the incubation and the digital imaging of agar culture plates streaked with micro

Official structured record identifier: 99302.

openFDA Device RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.

Official structured record identifier: 99300.

openFDA Device RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF

Official structured record identifier: 99299.

openFDA Device RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.

Official structured record identifier: 99295.

openFDA Device RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Stretto Model/Catalog Number: Q6 Edge 3 Stretto Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

Official structured record identifier: 99286.

openFDA Device RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog Number: MC2, MC2.1 Software Version: 5.7.0 Product Description: The MC2 Portable X-Ray System ( MC2 System or MC2 ) is a portable and handheld x-ray system designed to aid clinicians with point of care

Official structured record identifier: 99263.

openFDA Device RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System

Official structured record identifier: 99188.

openFDA Device RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A

Official structured record identifier: 99128.

openFDA Device RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No

Official structured record identifier: 99026.

openFDA Device RecallsOriginal source

🇺🇸Aug 12Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A

Official structured record identifier: 99025.

openFDA Device RecallsOriginal source