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High RiskFDA
Hiers Enterprises, Llc Dba Northwest Compounding Pharmacy
Cyclosporin liquid 1%, Rx, plastic dropper bottle
Drugs·0 affected·Jan 2, 2019
High RiskFDA
Hiers Enterprises, Llc Dba Northwest Compounding Pharmacy
Cyclosporin liquid 0.5%, Rx, plastic dropper bottle
Drugs·0 affected·Jan 2, 2019
High RiskFDA
Leica Microsystems, Inc.
Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for improving the visibility of ob...
Surgical Devices·15 affected·Jan 2, 2019
High RiskFDA
Abbott Laboratories, Inc
ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in human serum, plasma...
Diagnostic Devices·24,995 affected·Jan 2, 2019
High RiskFDA
Aurobindo Pharma Usa Inc.
Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-573-90.
Oral Drugs·20,604 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08...
Oral Drugs·55,788 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-570-30
Oral Drugs·0 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured ...
Oral Drugs·0 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90
Oral Drugs·0 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayto...
Oral Drugs·53,064 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayt...
Oral Drugs·92,616 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 088...
Oral Drugs·27,688 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayt...
Oral Drugs·111,239 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayt...
Oral Drugs·23,016 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08...
Oral Drugs·18,408 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-573-90
Oral Drugs·0 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-571-90
Oral Drugs·0 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayt...
Oral Drugs·32,160 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08...
Oral Drugs·60,417 affected·Dec 31, 2018
High RiskFDA
Kavo Dental Technologies Llc
cone-beam CT system
Medical Devices·230 affected·Dec 31, 2018
High RiskFDA
Ge Healthcare, Llc
GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: The device is intended f...
Cardiac Devices·1,897 affected·Dec 28, 2018
High RiskFDA
Fetzer Medical Gmbh & Co. Kg
12002 / Boss Instruments Simpson OB Forceps, short model, 13" (33cm), Item No./Product Code 46-5040 Fetzer Medical Obstetrical Forceps...
Surgical Devices·2 affected·Dec 28, 2018
High RiskFDA
Cardinal Health 200, Llc
Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm) Product Code: 8044 - Product Usage: Ideal for applying ointmen...
Medical Devices·10,400 affected·Dec 27, 2018
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC 68462-711-88) cartons, Ma...
Drugs·96,240 affected·Dec 26, 2018
High RiskFDA
Varian Medical Systems, Inc.
Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The Eclipse Treatment Planning Syst...
Medical Devices·1,450 affected·Dec 26, 2018
High RiskFDA
Boston Scientific Corporation
Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210
Medical Implants·18 affected·Dec 26, 2018
High RiskFDA
Lupin Somerset
Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; Ma...
Oral Drugs·23,460 affected·Dec 21, 2018
High RiskFDA
Philips Medical Systems Nederlands
Achieva XR 1.5T/3.0T, Model Number 781153. Nuclear Magnetic Resonance Imaging System
Medical Devices·11,226 affected·Dec 21, 2018
High RiskFDA
Philips Medical Systems Nederlands
SmartPath to dStream for XR and 3.0T, Model Number 781270. Nuclear Magnetic Resonance Imaging System
Medical Devices·11,226 affected·Dec 21, 2018
High RiskFDA
Philips Medical Systems Nederlands
Intera 1.5T Achieva CV Nova, Model Number 781174. Nuclear Magnetic Resonance Imaging System
Medical Devices·11,226 affected·Dec 21, 2018
High RiskFDA
Philips Medical Systems Nederlands
Enterprise 1.5T, Model Number 781145. Nuclear Magnetic Resonance Imaging System
Medical Devices·11,226 affected·Dec 21, 2018
High RiskFDA
Zimmer Biomet, Inc.
Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comprehensive Reve...
Medical Devices·52 affected·Dec 21, 2018
High RiskFDA
Philips Medical Systems Nederlands
SmartPath to dStream for 1.5T, Model Number 781260. Nuclear Magnetic Resonance Imaging System
Medical Devices·11,226 affected·Dec 21, 2018
High RiskFDA
Philips Medical Systems Nederlands
Intera 1.0T Power/Pulsar, Model Number 781103. Nuclear Magnetic Resonance Imaging System
Medical Devices·11,226 affected·Dec 21, 2018
High RiskFDA
Philips Medical Systems Nederlands
Ingenia Elition X, Model Number 781358. Nuclear Magnetic Resonance Imaging System
Medical Devices·11,226 affected·Dec 21, 2018
High RiskFDA
Philips Medical Systems Nederlands
Ingenia 3.0T, Model Number 781342. Nuclear Magnetic Resonance Imaging System
Medical Devices·11,226 affected·Dec 21, 2018
High RiskFDA
Philips Medical Systems Nederlands
MR RT, Model Number 781439. Nuclear Magnetic Resonance Imaging System
Medical Devices·11,226 affected·Dec 21, 2018
High RiskFDA
Philips Medical Systems Nederlands
Achieva 1.5T, Model Number 781296. Nuclear Magnetic Resonance Imaging System
Medical Devices·11,226 affected·Dec 21, 2018
High RiskFDA
Philips Medical Systems Nederlands
Intera Achieva 1.5T Nova, Model Number 781172. Nuclear Magnetic Resonance Imaging System
Medical Devices·11,226 affected·Dec 21, 2018
High RiskFDA
Philips Medical Systems Nederlands
Achieva 1.5T Conversion, Model Number 781283. Nuclear Magnetic Resonance Imaging System
Medical Devices·11,226 affected·Dec 21, 2018
High RiskFDA
Philips Medical Systems Nederlands
Intera 1.5T Explorer/Nova Dual, Model Number 781108. Nuclear Magnetic Resonance Imaging System
Medical Devices·11,226 affected·Dec 21, 2018
High RiskFDA
Philips Medical Systems Nederlands
Multiva 1.5T 8 R5 (ZBO), Model Number 781072. Nuclear Magnetic Resonance Imaging System
Medical Devices·11,226 affected·Dec 21, 2018
High RiskFDA
Philips Medical Systems Nederlands
Intera Achieva 1.5T Nova Dual, Model Number 781173. Nuclear Magnetic Resonance Imaging System
Medical Devices·11,226 affected·Dec 21, 2018
High RiskFDA
Philips Medical Systems Nederlands
Achieva 3.0T TX, Model Number 781345. Nuclear Magnetic Resonance Imaging System
Medical Devices·11,226 affected·Dec 21, 2018
High RiskFDA
Zimmer Biomet, Inc.
Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764
Medical Devices·45 affected·Dec 21, 2018
High RiskFDA
Philips Medical Systems Nederlands
Multiva 1.5T 8 R5, Model Number 781074. Nuclear Magnetic Resonance Imaging System
Medical Devices·11,226 affected·Dec 21, 2018
High RiskFDA
Philips Medical Systems Nederlands
Intera 1.5T, Model Number 781195. Nuclear Magnetic Resonance Imaging System
Medical Devices·11,226 affected·Dec 21, 2018
High RiskFDA
Philips Medical Systems Nederlands
Intera Achieva 1.5T Pulsar, Model Number 781171. Nuclear Magnetic Resonance Imaging System
Medical Devices·11,226 affected·Dec 21, 2018