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CriticalFDA
Baxter Healthcare Corp.
Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter ...
Injectable Drugs·7,388 affected·Nov 18, 2013
RecallFDA
Fougera Pharmaceuticals Inc.
KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, ND...
Topical Drugs·31,122 affected·Nov 18, 2013
CriticalFDA
Fossil Fuel Products, Llc
RezzRX capsules, Single Blister Pack and 20 count bottle, Distributed By: Fossil Fuel Products, LLC Atlanta, GA 30309
Oral Drugs·50,300 affected·Nov 18, 2013
CriticalFDA
Baxter Healthcare Corp.
Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection, 2000 mL CLARITY Dual Chamber...
Injectable Drugs·7,068 affected·Nov 18, 2013
CriticalFDA
Ss Wholesale Inc. Dba Jobbers Wholesale
MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterprise, Buena Park, CA 90621, UPC 6 10079 52468 2.
Oral Drugs·2,395 affected·Nov 18, 2013
CriticalFDA
Baxter Healthcare Corp.
Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Container bag, Rx only. Dist: Bax...
Injectable Drugs·14,574 affected·Nov 18, 2013
CriticalFDA
Ss Wholesale Inc. Dba Jobbers Wholesale
Rhino 5 capsules(Spanish & English Labeling), 1 capsule per blister pack, Distributed by P&A Enterprise, Buena Park, CA 90621, English U...
Oral Drugs·2,395 affected·Nov 18, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibi...
Medical Devices·29,235 affected·Nov 18, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibi...
Medical Devices·29,235 affected·Nov 18, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial ...
Medical Devices·29,235 affected·Nov 18, 2013
CriticalFDA
Abbott Diabetes Care, Inc.
FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 2; Freestyle Blood Glucose Test Stri...
Diabetes Devices·141,219 affected·Nov 18, 2013
High RiskFDA
Varian Medical Systems, Inc.
Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuit...
Medical Devices·6,701 affected·Nov 18, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proxima...
Medical Devices·29,235 affected·Nov 18, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proxim...
Medical Devices·29,235 affected·Nov 18, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal...
Medical Devices·29,235 affected·Nov 18, 2013
High RiskFDA
Medtronic Neurosurgery
Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201. Delta Shunt Assemblies are designe...
Medical Devices·34 affected·Nov 18, 2013
CriticalFDA
Abbott Diabetes Care, Inc.
FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count; 100 count Product of Ireland; UPC 6 99073 7081...
Diabetes Devices·141,219 affected·Nov 18, 2013
High RiskFDA
Medtronic Neurosurgery
Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata II Shunt Assemblies are designed to provide continued cerebr...
Cardiac Devices·5 affected·Nov 18, 2013
High RiskFDA
Cmp Industries, Llc
IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number...
Medical Devices·246 affected·Nov 18, 2013
High RiskFDA
Medtronic Neurosurgery
CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog ...
Medical Devices·288 affected·Nov 18, 2013
High RiskFDA
Pinnacle Foods, Llc
Aunt Jemima(R) HOMESTYLE FRENCH TOAST, 6 COUNT, NET WT. 12.5 OZ (354 g), UPC Code: 019600057703
Food·153 affected·Nov 17, 2013
High RiskFDA
Lewis Bakeries-evansville
White bread packaged under the following names and sizes: UPC Name, size 71025-00269 Holsum, Sof-Twist, Giant, 24 OZ 24126-010...
Bakery & Grains·365,847 affected·Nov 16, 2013
High RiskFDA
Lewis Bakeries-evansville
UPC Name 6000050617 French Toast Whole Wheat (bulk)
Food·19,890 affected·Nov 16, 2013
High RiskFDA
Lewis Bakeries-evansville
Whole Wheat Bread packaged under the following names and sizes: UPC Name, size 41498-18997 L'Oven Fresh, Wheat Sandwich, 20 OZ ...
Bakery & Grains·111,807 affected·Nov 16, 2013
High RiskFDA
Lewis Bakeries-evansville
UPC Name 6000283494 Yellow bread (bulk)
Bakery & Grains·87,210 affected·Nov 16, 2013
High RiskFDA
Lewis Bakeries-evansville
UPC Name 6000283495 Cinnamon Bread (bulk)
Bakery & Grains·18,360 affected·Nov 16, 2013
High RiskFDA
Tower Pharmacy And Compounding
Phenylephrine Nasal 1% Spray, 480 mL bottles, For Office Use, Tower Pharmacy, 26732 Crown Valley Pkwy, Suite 101, Mission Viejo, CA 92691
Inhaled / Nasal Drugs·2 affected·Nov 16, 2013
RecallCPSC
Toys R Us Stores Nationwide And Online At Toysrus.com From February 2013 To August 2013 For About $130.
Step2 Recalls Ride-On Wagon Toys Due to Fall Hazard; Sold Exclusively at Toys R Us
Toys·14,000 affected·Nov 15, 2013
High RiskFDA
Kirkman Group Inc.
Phenol Assist, Kirkman brand, Item # 0835-090
Food·1,774 affected·Nov 15, 2013
High RiskFDA
Physique Enhancing Science
Physique Enhancing Science ALPHAMINE, Powerful Thermogenic Powder, DIETARY SUPPLEMENT Net Wt. 8.9 oz (252 g). Raspberry Lemonade and Frui...
Produce·12,363 affected·Nov 15, 2013
High RiskFDA
Kirkman Group Inc.
EnZym-Complete/DPP-IV II with Isogest, Kirkman brand. Item numbers: 0851A-090, 0851A-180, 0931-090, 0931-180, 5851A-090, 5931-090.
Food·9,486 affected·Nov 15, 2013
High RiskFDA
Lotus Foods Inc
Organic Jade Pearl RICE RAMEN; Gluten Free/Vegan, Infused Noodles Ready in 4 minutes; Net Wt. 10 oz; (283 g) ramen per bag USDA Organ...
Food·8,496 affected·Nov 15, 2013
High RiskFDA
Kirkman Group Inc.
Enzym-Complete/DPP-IV, Kirkman brand. Item numbers 0234-060, 0234-120, 0234-200, 5234-200
Food·11,944 affected·Nov 15, 2013
High RiskFDA
Lotus Foods Inc
Organic Millet & Brown RICE RAMEN; Gluten Free/Vegan Ready in 4 minutes; Net Wt. 10 oz; (283g) 4 ramen per bag USDA Organic; Lotus ...
Food·8,568 affected·Nov 15, 2013
High RiskFDA
Kirkman Group Inc.
Chewable Maximum Spectrum EnZym-Complete/DPPIV with Isogest, Kirkmand brand. Item # 0893-090
Food·79 affected·Nov 15, 2013
High RiskFDA
Physique Enhancing Science
Physique Enhancing Science ENHANCED, Ultra Advanced Pre-Workout, DIETARY SUPPLEMENT Net Wt. 5.22 oz (148 g). In BlueRazz and Fruit Punch...
Produce·28,804 affected·Nov 15, 2013
High RiskFDA
Lotus Foods Inc
Jade Pearl RICE RAMEN with miso soup Gluten Free/Reduced Sodium; made with organic rice Ready in 4 minutes; Net Wt.2.8 oz. (80 g) 1 Ra...
Food·18,150 affected·Nov 15, 2013
High RiskFDA
Lotus Foods Inc
Forbidden RICE RAMEN with miso soup Gluten Free/Reduced Sodium; made with organic rice Ready in 4 minutes; Net Wt.2.8 oz. (80 g) 1 Ram...
Food·18,000 affected·Nov 15, 2013
High RiskFDA
Lotus Foods Inc
Millet & Brown RICE RAMEN with miso soup Gluten Free/Reduced Sodium; made with organic rice Ready in 4 minutes; Net Wt.2.8 oz. (80 g)...
Food·18,000 affected·Nov 15, 2013
High RiskFDA
Kirkman Group Inc.
Biofilm Defense, Kirkman brand, Item # 0881-060 and 5881-060 Biofilm Defense, Pure Compounding brand, Item # 1881-060.
Food·6,099 affected·Nov 15, 2013
High RiskFDA
Blount Fine Foods Corporation
Wegman's Brand New England Clam Chowder (refrigerated at 38F or below) in a 16 oz plastic cup.
Food·140 affected·Nov 15, 2013
High RiskFDA
Kirkman Group Inc.
Maximum Spectrum EnZym-Complete/DPP-IV Fruit Free w/Isogest, Kirkman brand, Item # 0869A-120 and 0932-120.
Produce·2,273 affected·Nov 15, 2013
Medium RiskFDA
Actavis Inc
BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3...
Oral Drugs·139,944 affected·Nov 15, 2013
High RiskFDA
Instrumentation Laboratory Co.
HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
Diagnostic Devices·84,561 affected·Nov 15, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.
Medical Devices·147 affected·Nov 15, 2013
High RiskFDA
Intuitive Surgical, Inc.
Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA...
Surgical Devices·15 affected·Nov 15, 2013
High RiskFDA
Instrumentation Laboratory Co.
HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
Diagnostic Devices·80,319 affected·Nov 15, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System. Product Usage: The angiographic X-ray systems...
Surgical Devices·28 affected·Nov 15, 2013