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High RiskFDA
American Medical Systems Innovation Center - Silicon Valley
Fiber Stripper, 365¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endos...
Medical Devices·16,710 affected·May 28, 2015
High RiskFDA
American Medical Systems Innovation Center - Silicon Valley
1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex F...
Medical Devices·16,710 affected·May 28, 2015
High RiskFDA
Novacare, Llc
Glucosamine 750 mg 120 ct, Capsule, Dosage: 12 capsules, 750 mg ea., three times daily with meals
Food·961 affected·May 27, 2015
High RiskFDA
Musculoskeletal Transplant Foundation, Inc.
Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze.
Medical Devices·22 affected·May 27, 2015
High RiskFDA
Ptw-freiburg
PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic rad...
Diagnostic Devices·242 affected·May 27, 2015
High RiskFDA
Musculoskeletal Transplant Foundation, Inc.
Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs of the orth...
Surgical Devices·117 affected·May 27, 2015
High RiskFDA
Synthes, Inc.
DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur...
Medical Devices·276 affected·May 27, 2015
High RiskFDA
Bausch & Lomb Surgical, Inc.
Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for primary implantation in the...
Medical Implants·72,773 affected·May 26, 2015
High RiskFDA
Bausch & Lomb Surgical, Inc.
Bausch & Lomb SofPort Advanced Optics Aspheric Lens
Medical Devices·72,773 affected·May 26, 2015
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. ...
Medical Devices·15,798 affected·May 26, 2015
High RiskFDA
Smiths Medical Asd, Inc.
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provid...
Medical Devices·4,426 affected·May 26, 2015
High RiskFDA
Whole Foods Market
Jivara Lactee Milk Chocolate Valrhona; 40% Ingredients: Cocoa Butter, whole powdered milk, sugar, cocoa beans, brown sugar, natural vani...
Dairy·0 affected·May 23, 2015
High RiskFDA
Falcon Trading Co., Inc.
Sunridge Candy-Coconut Chews, Vanilla. 10 lb. box. Item code: 023617; UPC: 086700936177 Falcon Trading Company Inc/Sun Ridge Farms,...
Snacks & Candy·156 affected·May 22, 2015
High RiskFDA
Falcon Trading Co., Inc.
Conventional Desiccated Coconut - Medium Shred 25 lb. bags. Exp date: 20.11.2015 Item code: 001120; UPC: 086700011201 Imported by Fa...
Food·726 affected·May 22, 2015
High RiskFDA
Blenheim Pharmacal, Inc.
Captopril Tablets, USP, 50 mg, 30 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Packaged By: Blenheim Pharmacal I...
Oral Drugs·166 affected·May 22, 2015
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited Bachupall...
Oral Drugs·5,160 affected·May 22, 2015
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-...
Oral Drugs·100 affected·May 22, 2015
High RiskFDA
Blenheim Pharmacal, Inc.
Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Repackaged By: Blenheim Phar...
Oral Drugs·50 affected·May 22, 2015
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra (120V) 0702-001-000R, Repair Neptune 2 Rover 0702-002-000,...
Surgical Devices·9,245 affected·May 22, 2015
High RiskFDA
Medtech Products, Inc.
SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: Insight Pharmaceuticals, LLC, Trevose, PA 19053-8433
Drugs·107,832 affected·May 21, 2015
High RiskFDA
Takeda Pharmaceuticals North America, Inc.
CONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 90 mg, 120-count bottle, Rx only, Manufactured for Orexigen T...
Oral Drugs·3,619 affected·May 21, 2015
High RiskFDA
Exactech, Inc.
Exactech Single Barrel Drill Guides The Single Barrel Drill Guide is a nonpowered hand-held device intended for medical purposes to mani...
Medical Devices·2 affected·May 21, 2015
High RiskFDA
Baxter Healthcare Corp
ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT
Surgical Devices·23,600 affected·May 21, 2015
High RiskFDA
Intuitive Surgical, Inc.
Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic manipulation of tis...
Surgical Devices·2,436 affected·May 21, 2015
High RiskFDA
Exactech, Inc.
Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-...
Medical Devices·4 affected·May 21, 2015
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System,...
Medical Implants·18 affected·May 21, 2015
High RiskFDA
Texas Pack, Inc.
Brown Peeled and De-veined Shrimp, (U/10, U/12, 10/15, 16/20, 21/25, 26/30, 31/35, 36/40, 41/50, 51/60, 61/70, 71/80, 81/90, Large Pcs, M...
Seafood·3,653 affected·May 20, 2015
High RiskFDA
Mylan Lab Inc
Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., N...
Oral Drugs·7,722 affected·May 20, 2015
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB ...
Medical Devices·1,856,619 affected·May 20, 2015
High RiskFDA
Northern Digital Inc.
NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product Usage: Disposable reflective marker ...
Surgical Devices·32,400 affected·May 20, 2015
High RiskFDA
Pointe Scientific, Inc.
Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). Also sold as individual ...
Diabetes Devices·2,772 affected·May 19, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab aut...
Medical Devices·1,941 affected·May 19, 2015
High RiskFDA
Remel Inc
VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorga...
Medical Devices·143 affected·May 19, 2015
High RiskFDA
Michael Zakany Llc
Jose Madrid Salsa Mild NET WT. 13 OZ. (369 g.) www.josemadridsalsa.com Jose Madrid Salsa PO Box 1061 Zanesville, OH 43702 740.221.3934 RE...
Food·8 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
HYDROXYZINE HYDROCHLORIDE (STERILE WATER) (10ML VIAL) 25MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywoo...
Injectable Drugs·2 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
SODIUM TETRADECYL SULFATE (STERILE WATER) (30ML) 3.5% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Injectable Drugs·1 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
HYDROXYPROGESTERONE CAPROATE (OLIVE OIL) 30ML, 10ML VIAL 250MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Holl...
Injectable Drugs·28 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
HYDROXYZINE HYDROCHLORIDE (30ML VIAL) (STERILE WATER) 50MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywoo...
Injectable Drugs·3 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
ESTRADIOL CYPIONATE (SESAME OIL) (10ML, 30ML VIAL) 40MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood,...
Injectable Drugs·6 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
ESTRADIOL VALERATE (SESAME OIL) 10ML VIAL 10MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Injectable Drugs·1 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
NANPYRIDOXINE (STERILE WATER) 30ML 50MG/ML INJECTABLE,Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Injectable Drugs·30 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
DMSO (STERILE WATER) SOLUTION -50ML VIAL 50% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Injectable Drugs·41 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
NANDROLONE DECANOATE (SESAME OIL) 100ML VIAL 200MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 9...
Injectable Drugs·32 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
ESTRADIOL VALERATE (10ML VIAL) SESAME OIL 45MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Injectable Drugs·17 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
GLUTATHIONE 200MG/ML (STERILE WATER) (30ML, 50ML VIAL) INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA ...
Injectable Drugs·0 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
SODIUM HYALURONATE (2ML PREFILLED SYRINGE) STERILE WATER 20MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Holly...
Injectable Drugs·416 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
SODIUM HYALURONATE (STERILE WATER) 2.5 ML VIAL 20MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 9...
Injectable Drugs·21 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
VITAMIN D3 (OLIVE OIL) (30ML VIAL) 50,000 UNITS/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Injectable Drugs·2 affected·May 18, 2015