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High RiskFDA
Pentec Health
Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 485mL bag and b) 490mL bag, P...
Drugs·25 affected·May 15, 2013
High RiskFDA
Novartis Consumer Health
Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets. Distributed by: Novartis Consumer Health, Inc., Parsi...
Drugs·2,978,000 affected·May 15, 2013
High RiskFDA
Pentec Health
IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a) 490mL bag, b) 500mL bag, and c) 590mL bag, Pent...
Drugs·3 affected·May 15, 2013
RecallFDA
Novartis Consumer Health
Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in a) 8 coat...
Drugs·98,024 affected·May 15, 2013
High RiskFDA
Health & Beyond
HEALTH & BEYOND DR. LARRY'S Tranquility DIETARY SUPPLEMENT 30 Capsules Manufactured for: Health & Beyond 7050 W Palmetto Pk Rd Boca Raton...
Oral Drugs·46 affected·May 15, 2013
RecallFDA
Mylan Institutional, Inc. (d.b.a. Udl Laboratories)
Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box, Rx only, M...
Oral Drugs·1,621 affected·May 15, 2013
High RiskFDA
Pentec Health
Proplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in 555mL bag, Pentec Health Inc, 4 ...
Drugs·59 affected·May 15, 2013
RecallFDA
Novartis Consumer Health
Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg,Phenylephr...
Drugs·32,256 affected·May 15, 2013
RecallFDA
Novartis Consumer Health
Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBr 10mg, Phenylep...
Drugs·38,856 affected·May 15, 2013
High RiskFDA
Pentec Health
Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 385mL and b) 390mL, Pentec He...
Drugs·9 affected·May 15, 2013
High RiskFDA
Actavis South Atlantic Llc
Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactured by VistaPharm, Inc., Birmingham, AL 35242. Distributed ...
Oral Drugs·133,968 affected·May 15, 2013
Medium RiskFDA
Novartis Consumer Health
Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine HCL 5mg, packaged in 12 ...
Drugs·167,712 affected·May 15, 2013
High RiskFDA
Biomet, Inc.
Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of ...
Medical Devices·17 affected·May 15, 2013
High RiskFDA
Baxter Healthcare Corp.
Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4030 - Approximate Length 98" (2.5. m) ...
Medical Devices·530,488 affected·May 15, 2013
High RiskFDA
Sysmex America Inc
pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo...
Diagnostic Devices·193 affected·May 15, 2013
High RiskFDA
Baxter Healthcare Corp.
Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.2. m) Usage: ...
Medical Devices·356,728 affected·May 15, 2013
High RiskFDA
Tosoh Smd Inc
AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag AIA-Analyzer Tips are dispo...
Diagnostic Devices·11,309 affected·May 15, 2013
High RiskFDA
Baxter Healthcare Corp.
Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4031 -Approximate Length 99" (2.5. m) ...
Medical Devices·249,576 affected·May 15, 2013
High RiskFDA
Spine Wave, Inc.
StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for int...
Medical Implants·17 affected·May 14, 2013
RecallFDA
Optovue, Inc.
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
Medical Devices·329 affected·May 14, 2013
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric...
Medical Devices·100 affected·May 14, 2013
High RiskFDA
Ge Healthcare, Llc
Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. Intended to provide general inhalation anesthe...
Respiratory Devices·800 affected·May 14, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur¿ iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH assays.
Diagnostic Devices·198 affected·May 14, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitro diagnostic use in the quantitative determ...
Diagnostic Devices·3,302 affected·May 14, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.
Diagnostic Devices·99 affected·May 14, 2013
CriticalFDA
Zydus Pharmaceuticals Usa Inc
Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distribu...
Oral Drugs·960 affected·May 13, 2013
CriticalFDA
Abrams Royal Pharmacy
Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as sulfate), 0.4 mg Copper (as sulfate), 0.1 mg Manganese (as ...
Injectable Drugs·21 affected·May 13, 2013
RecallFDA
West-ward Pharmaceutical Corp.
Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir,...
Injectable Drugs·1,201 affected·May 13, 2013
CriticalFDA
Endologix Inc
Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: The AFX Int...
Surgical Devices·53 affected·May 13, 2013
High RiskFDA
Microgenics Corporation
Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corpora...
Medical Implants·188 affected·May 13, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens AXIOM Artis zeego x-ray, angiographic system
Medical Devices·132 affected·May 13, 2013
High RiskFDA
Life Technologies Corporation
HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use...
Diagnostic Devices·15 affected·May 13, 2013
High RiskFDA
Coloplast Manufacturing Us, Llc
Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. The Digitex Delivery Device ...
Medical Devices·772 affected·May 13, 2013
CriticalCPSC
Meijer Stores From September 2011 Through February 2013 For About $50.
Meijer Recalls Touch Point Baseboard Convection Heaters Due to a Fire Hazard
Furniture·4,560 affected·May 10, 2013
High RiskFDA
Bimbo Bakeries Usa
Foodservice Hamburger Buns - 12 Count Earthgrains Baking companies, Inc. Horsham, PA 19044
Food·5,326 affected·May 10, 2013
High RiskFDA
Bimbo Bakeries Usa
Hot Dog Buns 8 Count Earthgrains Baking companies, Inc. Horsham, PA 19044
Food·8,572 affected·May 10, 2013
High RiskFDA
Bimbo Bakeries Usa
Kerns Beef Buns - 12 count Distributed By: K-VA-T Food Stores, Inc., Arbingdon, VA 24210
Meat & Poultry·812 affected·May 10, 2013
High RiskFDA
Bimbo Bakeries Usa
Kroger White Jumbo Hamburger Buns - 8 Buns Distributed By: The Kroger Co. Cincinnati, Ohio 45202
Food·214 affected·May 10, 2013
RecallFDA
Bao Gong Da Inc
Ginseng. American Ginseng, 4 oz. and 8 oz. retail packages and bulk ginseng in 20, 30, or 40 lbs. in a clear plastic bag. Bulk product...
Food·2,422 affected·May 10, 2013
High RiskFDA
Bimbo Bakeries Usa
Great Value 8 Jumbo Hamburger Buns Distributed By: Wal-Mart Stores, inc., Bentonville, AR 72716
Food·336 affected·May 10, 2013
High RiskFDA
Bimbo Bakeries Usa
8 Bakery Buns Sara Lee Hearty & Delicious Sesame Seed and Sara Lee Gourmet Sesame Seed Hamburger Buns Restaurant Style - 12 count Sa...
Food·8 affected·May 10, 2013
High RiskFDA
Bimbo Bakeries Usa
Sara Lee Classic White 12 Hamburger Buns Sara Lee, Downers Grove, IL 60515
Food·39 affected·May 10, 2013
High RiskFDA
Bimbo Bakeries Usa
Kroger Sandwich Enriched Buns - 12 count Distributed By: The Kroger Co., Cincinnati, Ohio 45202
Food·65 affected·May 10, 2013
High RiskFDA
Smiling Hill Farm, Inc. Dba Silvery Moon Creamery
Smiling Hill Farm brand Butter, 1/2 lb, 5 lb; Unlabeled: 1/2 lb, 5 lb, 30-40 lb (variable in 5 gallon buckets) Product in plastic snap-...
Dairy·9,046 affected·May 10, 2013
High RiskFDA
Bimbo Bakeries Usa
Hamburger Buns Bimbo Bakeries USA 255 Business Center Dr. Horsham, PA 19044 Food Service Hamburger Buns, Seeded and Unseeded, al...
Food·264 affected·May 10, 2013
High RiskFDA
Bimbo Bakeries Usa
Colonial 12 Seeded Enriched Buns Sara Lee, Downers, Grove, IL 60515
Food·868 affected·May 10, 2013
High RiskFDA
Gromex Inc.
Gromex Camaron Entero (Whole Shrimp) Net Wt. 1 1/2 oz. 43 First St., Passaic, NJ 07055 (973) 458-9399
Seafood·0 affected·May 10, 2013
High RiskFDA
Bimbo Bakeries Usa
8 Bakery Buns Sara Lee Hearty & Delicious White Sara Lee, Downers Grove, IL 60515
Food·1,505 affected·May 10, 2013