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High RiskFDA
Burel Pharmaceuticals Inc
AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate...
Oral Drugs·604 affected·Oct 24, 2016
High RiskFDA
Burel Pharmaceuticals Inc
Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, ...
Oral Drugs·17,788 affected·Oct 24, 2016
High RiskFDA
Burel Pharmaceuticals Inc
URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 118 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate ...
Oral Drugs·2,771 affected·Oct 24, 2016
High RiskFDA
Burel Pharmaceuticals Inc
Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methy...
Oral Drugs·2,861 affected·Oct 24, 2016
High RiskFDA
Burel Pharmaceuticals Inc
Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, M...
Oral Drugs·795 affected·Oct 24, 2016
High RiskFDA
Burel Pharmaceuticals Inc
UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylate 36 mg, Methylen...
Oral Drugs·823 affected·Oct 24, 2016
High RiskFDA
Burel Pharmaceuticals Inc
UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic Sodium Phosphate 40.8 mg, Phen...
Oral Drugs·11,539 affected·Oct 24, 2016
High RiskFDA
Beckman Coulter Inc.
Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase Calibrators are intended to calibrate the Acces...
Diagnostic Devices·357 affected·Oct 24, 2016
High RiskFDA
Domain Surgical, Inc.
FMsealer Open Shears. Model FM3001
Medical Devices·70 affected·Oct 24, 2016
High RiskFDA
Sokol And Co
Solo Almond Paste, 6/7 LB. Cans, Net Weight: 42 LBS. (19.09 KG.)
Food·486 affected·Oct 21, 2016
High RiskFDA
Akorn Inc
Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.
Ophthalmic Drugs·29,972 affected·Oct 21, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
Medical Devices·23 affected·Oct 21, 2016
High RiskFDA
Brownwood Farms
Brownwood Farms Michigan Cherry Preserves 12oz glass bottles and 1 gallon. Private labels: Art's Tavern (Cherry Preserves 12oz).
Food·115,195 affected·Oct 20, 2016
High RiskFDA
Brownwood Farms
Brownwood Farms Jalapeno Cherry Butter 12oz and 20oz glass bottles and 1 gallon. Private labels: Kimmel Orchard & Vineyard (Jalapeno C...
Dairy·17,024 affected·Oct 20, 2016
High RiskFDA
Brownwood Farms
Brownwood Farms America's Original Cherry Butter 12oz and 22oz glass bottles and 1 gallon. Private labels: Arbor Day Farm (Cherry But...
Dairy·52,510 affected·Oct 20, 2016
High RiskFDA
Brownwood Farms
Brownwood Farms Pear & Cinnamon Preserves 10oz glass bottles and 1 gallon.
Food·17,059 affected·Oct 20, 2016
High RiskFDA
Mevion Medical Systems, Inc.
MEVION S250 Product Usage: Proton Radiation Therapy System
Medical Devices·6 affected·Oct 20, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Force, System x-ray, tomography, computed
Medical Devices·48 affected·Oct 20, 2016
High RiskFDA
Micromedics, Inc.
Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide
Surgical Devices·273 affected·Oct 20, 2016
High RiskFDA
Myers Cider Mill, Llc
100% APPLE CIDER 1 Gallon (3.78L) UV TESTED KEEP REFRIGERATED UPC 0 85591 00128 1
Food·200 affected·Oct 19, 2016
High RiskFDA
Inventia Healthcare Private Limited
Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Manufactured by: Inventia Healthcare Private Limited Additional...
Oral Drugs·46,848 affected·Oct 19, 2016
High RiskFDA
Ultroid Technologies, Inc.
Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes
Medical Devices·1,129 affected·Oct 19, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Flash, Computed tomography system Product Usage: SOMATOM Definition AS systems are intended to produce cross-secti...
Medical Devices·3,077 affected·Oct 19, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP s...
Diagnostic Devices·18,733 affected·Oct 19, 2016
High RiskFDA
Ultroid Technologies, Inc.
Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes.
Medical Devices·52,084 affected·Oct 19, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP s...
Diagnostic Devices·30,222 affected·Oct 19, 2016
High RiskFDA
Ultroid Technologies, Inc.
Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes
Medical Devices·62 affected·Oct 19, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition Flash systems are intended to produce cross-secti...
Medical Devices·762 affected·Oct 19, 2016
High RiskFDA
Beckman Coulter Inc.
AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer sys...
Diagnostic Devices·2,367 affected·Oct 19, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition AS system, x-ray, tomography, computed
Medical Devices·57 affected·Oct 19, 2016
High RiskFDA
Ultroid Technologies, Inc.
Ultroid Sterile Disposable Probes sold individually
Medical Devices·7,784 affected·Oct 19, 2016
High RiskFDA
1 Epic, Llc
Fruit 66 Tropical Punch, 8 FL OZ (240 mL) 100% Juice Non-Carbonated. Flavored 100% Juice Blend from concentrate with other natural Flavo...
Beverages·6,552 affected·Oct 18, 2016
High RiskFDA
1 Epic, Llc
Fruit 66 Strawberry Melon, 8 FL OZ (240 mL) 100% Juice Non-Carbonated. Flavored 100% Juice Blend from concentrate with other natural Fla...
Beverages·5,688 affected·Oct 18, 2016
High RiskFDA
1 Epic, Llc
Fruit 66 Mixed Berry, 8 FL OZ (240 mL) 100% Juice Non-Carbonated. Flavored 100% Juice Blend from concentrate with other natural Flavors ...
Beverages·1,944 affected·Oct 18, 2016
High RiskFDA
1 Epic, Llc
Fruit 66 Passion Fruit Mango, 8 FL OZ (240 mL) 100% Juice Non-Carbonated. Flavored 100% Juice Blend from concentrate with other natural ...
Beverages·5,832 affected·Oct 18, 2016
High RiskFDA
Teleflex Medical
Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed Tracheal Tube, Catalog # 5-10315 A tracheal tube is inserte...
Medical Devices·25,274 affected·Oct 18, 2016
High RiskFDA
Spacelabs Healthcare Inc
Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal ...
Medical Devices·348 affected·Oct 18, 2016
High RiskFDA
Conformis, Inc.
ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for use as a total k...
Medical Implants·2 affected·Oct 18, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems
Medical Devices·3 affected·Oct 17, 2016
High RiskFDA
Helena Laboratories, Inc.
Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
Medical Devices·65 affected·Oct 14, 2016
High RiskFDA
Reshape Medical Inc
ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110 product Usage: The ReShape Integrated Dual B...
Medical Devices·114 affected·Oct 14, 2016
High RiskFDA
Cinnabar Specialty Foods, Inc.
Neeras Spicy Thai Sauce and Marinade, Net Volume 150ml/5 fl. oz.., 12 units/case, or 6 units/partial case, 2.0 gallon pail.
Food·41 affected·Oct 13, 2016
High RiskFDA
C.r. Bard, Inc.
Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
Medical Devices·75,089 affected·Oct 13, 2016
High RiskFDA
C.r. Bard, Inc.
BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
Medical Implants·75,089 affected·Oct 13, 2016
High RiskFDA
Perkinelmer, Inc
PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677. Used with the: JANUS AUTOMATED WORKSTATION Product Codes...
Medical Devices·33,312 affected·Oct 13, 2016
High RiskFDA
Nobel Bakery
Apricot Perouk, Net Wt. 10 oz. (283g), UPC 7 80890 28601 1.
Food·0 affected·Oct 12, 2016
High RiskFDA
Nobel Bakery
Orange Cake, Net Wt. 10 oz. (283g), UPC 7 80890 28604 2.
Bakery & Grains·0 affected·Oct 12, 2016
High RiskFDA
Unilever United States, Inc.
Ben & Jerrys Brownie Batter Core Ice Cream One Pint (473 mL). Case UPC- 10076840529879 Consumer UPC - 7684052987 Paper carton 8 un...
Dairy·194,952 affected·Oct 12, 2016