Retiros de la FDA, junio 2020: 156 publicados

85 empresas distintas aparecen este mes.

Clasificación de riesgo: Class I: 15 · Class II: 134 · Class III: 7

Mismo mes, otras agencias:CPSC 16 retirosFSIS 11 retirosNHTSA 73 retiros

Retiros del mes

FechaProducto
17 de junio de 2020STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product U…Z-2328-2020Intuitive Surgical, Inc.
17 de junio de 2020Healthy Choice Pesto and Egg bowls labeled in the following ways: 1) (for the US market) …F-0982-2020ConAgra Foods, INc.
17 de junio de 2020Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 …Z-2337-2020Philips North America, LLC
17 de junio de 2020Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, threaded) - Pr…Z-2275-2020Genicon, Inc.
17 de junio de 2020Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) …Z-2302-2020Siemens Medical Solutions USA, Inc
17 de junio de 2020Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (…D-1296-2020Fresenius Kabi USA, LLC
17 de junio de 2020Bin Butternut Squash, Bulk, Raw Product in Bins / 4, 5lb packages in each caseF-0978-2020Coastal Sunbelt Produce Co. Inc.
17 de junio de 2020Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/c…D-1306-2020Pfizer Inc.
17 de junio de 2020A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM, Item Number: 110…Z-2306-2020Biomet
17 de junio de 2020smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the followin…Z-2331-2020Smith & Nephew, Inc.
17 de junio de 2020Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: …Z-2289-2020Elekta, Inc.
17 de junio de 2020ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number…Z-2280-2020Siemens Healthcare Diagnostics, Inc.
17 de junio de 2020FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used wit…Z-2295-2020BioFire Diagnostics, LLC
17 de junio de 2020Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: …D-1291-2020UNICHEM PHARMACEUTICALS USA INC
17 de junio de 2020RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy …Z-2340-2020RAYSEARCH LABORATORIES AB
10 de junio de 2020Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set …Z-2196-2020Baxter Healthcare Corporation
10 de junio de 2020Organic Ground Oregano, Item # 90206. Packaged in 40 lbs. or 50 lbs. cases and sold unde…F-0974-2020K F K Seasonings Llc
10 de junio de 2020Sterile Custom Packs to be used in surgical procedures.Z-2177-2020American Contract Systems
10 de junio de 2020OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The prod…Z-2188-2020Osteomed, LLC
10 de junio de 2020Plucker's Wing Bar World Famous Wing Sauce Spicy Mandarin 12 FL OZ. (355 mL) packaged in …F-0991-2020Zilks Foods
10 de junio de 2020PerkinElmer 226 Sample Collection DeviceZ-2264-2020PerkinElmer Health Sciences, Inc.
10 de junio de 2020Sterile Custom Packs to be used in surgical procedures.Z-2176-2020American Contract Systems
10 de junio de 2020da Vinci SP surgical systemZ-2260-2020Intuitive Surgical, Inc.
10 de junio de 2020Garlic Sauce; Net Wt. 8LB. (3.62 kg); PJ Item #1104; UPC 26700 16345; Manufactured for: P…F-0971-2020Ventura Foods Llc
10 de junio de 2020Plucker's Wing Bar World Famous Wing Sauce Baker's Gold 12 FL OZ. (355 mL) packaged in a …F-0986-2020Zilks Foods
10 de junio de 2020Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X60MM, Item Number 811M8560…Z-2232-2020Zimmer Biomet, Inc.
10 de junio de 2020Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X50MM, Item Number 810M555…Z-2217-2020Zimmer Biomet, Inc.
10 de junio de 2020Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphet…D-1285-2020Teva Pharmaceuticals USA
10 de junio de 2020Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphet…D-1287-2020Teva Pharmaceuticals USA
10 de junio de 2020ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP comp…Z-2257-2020Siemens Medical Solutions USA, Inc
10 de junio de 2020Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X40MM, Item Number 810M654…Z-2224-2020Zimmer Biomet, Inc.
10 de junio de 2020Cherrybrook Kitchen***Gluten Free***Wheat Free***SUGAR COOKIE MIX***NET WT. 13 OZF-1001-2020Cell-nique Corp
10 de junio de 2020Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904…D-1288-2020The Harvard Drug Group
10 de junio de 2020NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R…Z-2207-2020Nobel Biocare Usa Llc
10 de junio de 2020NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx Only, Manuf…D-1298-2020Acella Pharmaceuticals, LLC
10 de junio de 2020Plucker's Wing Bar World Famous Wing Sauce Teriyaki 12 FL OZ. (355 mL) packaged in a glas…F-0992-2020Zilks Foods
10 de junio de 2020Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine , REF 33830…Z-2239-2020Beckman Coulter Inc.
10 de junio de 2020Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763…Z-2206-2020Medtronic Inc.
10 de junio de 2020Plucker's Wing Bar World Famous Wing Sauce Gochujang 12 FL OZ. (355 mL) packaged in a gla…F-0987-2020Zilks Foods
10 de junio de 2020Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF 3…Z-2241-2020Beckman Coulter Inc.
10 de junio de 2020NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg), 100-count bottles, Rx Only, Manufac…D-1299-2020Acella Pharmaceuticals, LLC
10 de junio de 2020Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 c…D-1289-2020AVKARE Inc.
10 de junio de 2020Plucker's Wing Bar World Famous Wing Sauce Vampire Killer 12 FL OZ. (355 mL) packaged in …F-0993-2020Zilks Foods
10 de junio de 2020Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X55MM, Item Number 810M655…Z-2222-2020Zimmer Biomet, Inc.
10 de junio de 2020Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured …D-1317-2020Torrent Pharma Inc.
10 de junio de 2020Plucker's Wing Bar World Famous Wing Sauce Gold Rush 12 FL OZ. (355 mL) packaged in a gla…F-0988-2020Zilks Foods
10 de junio de 2020Sienna brand 4.25 oz. Cranberry Orange Muffins coded 20 071 31BF-0985-2020BAKE'N JOY FOODS, INC.
10 de junio de 2020Chili Powder, Mild, Organic is a blend, Item # 90030. Packaged in 1 lb. bags and sold un…F-0972-2020K F K Seasonings Llc
10 de junio de 2020Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI: 1509959…Z-2240-2020Beckman Coulter Inc.
10 de junio de 2020OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The p…Z-2181-2020Osteomed, LLC

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