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High RiskFDA
Jean's Cake
Coffee Cake: queso/guava (cheese/guava)
Dairy·550 affected·Aug 16, 2013
High RiskFDA
Jean's Cake
Coffee Cake: queso/fresa (cheese/strawberry)
Dairy·0 affected·Aug 16, 2013
High RiskFDA
Hospira Inc.
Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake Forest, IL...
Injectable Drugs·72,300 affected·Aug 16, 2013
High RiskFDA
Covidien Llc
Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881580123 Product Usage: Both 0.9% Sodium Chlorid...
Medical Devices·0 affected·Aug 16, 2013
High RiskFDA
Zeppessis Reprocessing, Llc
Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems: The Neptune Wa...
Surgical Devices·0 affected·Aug 16, 2013
High RiskFDA
Covidien Llc
Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 8881570121 Product Usage: Both 0.9% Sodium Ch...
Medical Devices·3,235,860 affected·Aug 16, 2013
High RiskFDA
Covidien Llc
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881590125 Product Usage: Both 0.9% Sodium Chlo...
Medical Devices·330,120 affected·Aug 16, 2013
High RiskFDA
Covidien Llc
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881590123 Product Usage: Both 0.9% Sodium Chlori...
Medical Devices·0 affected·Aug 16, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techn...
Medical Devices·732 affected·Aug 16, 2013
High RiskFDA
Access Scientific Inc
POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access to the vascular system to sample blo...
Surgical Devices·160 affected·Aug 16, 2013
High RiskFDA
Covidien Llc
Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881580125 Product Usage: Both 0.9% Sodium Chlorid...
Medical Devices·0 affected·Aug 16, 2013
High RiskFDA
Covidien Llc
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID: 8881590121 Product Usage: Both 0.9% Sodium Chlor...
Medical Devices·0 affected·Aug 16, 2013
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX o...
Cardiac Devices·1,182 affected·Aug 15, 2013
High RiskFDA
Steris Corporation
Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equipment Management Systems (EMS) are u...
Surgical Devices·127 affected·Aug 15, 2013
High RiskFDA
Hospira Inc.
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Units x 20 mL Single patient infusion vials per carton, Rx only,...
Injectable Drugs·283,150 affected·Aug 14, 2013
High RiskFDA
Novocol Pharmaceutical Of Canada
Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For Dental Block and Infiltration Only, 50 Cartridges per box - ...
Injectable Drugs·12,497 affected·Aug 14, 2013
High RiskFDA
Teva Pharmaceuticals Usa, Inc.
CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11
Injectable Drugs·780 affected·Aug 13, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . scanner designed to support high resolution, high ...
Cardiac Devices·828 affected·Aug 13, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum followin...
Medical Devices·319 affected·Aug 13, 2013
High RiskFDA
Tornier, Inc
AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument se...
Medical Implants·2,298 affected·Aug 13, 2013
High RiskFDA
Mariposa Baking Co.
Penguinos - four cream filled chocolate cupcakes: gluten, wheat & dairy free & vegan; 4 x 2.2oz cupcakes, net wt 8.8 oz. Ingredients: ...
Dairy·48 affected·Aug 12, 2013
High RiskFDA
Hospira, Inc.
Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01
Drugs·345,800 affected·Aug 12, 2013
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter,...
Medical Devices·311 affected·Aug 12, 2013
High RiskFDA
Microaire Surgical Instruments, Llc
Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled i...
Medical Implants·15,786 affected·Aug 12, 2013
High RiskFDA
Deroyal Industries Inc
DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE...
Surgical Devices·726 affected·Aug 12, 2013
High RiskFDA
Churchill Medical Systems, Inc.
Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids.
Medical Devices·13,100 affected·Aug 12, 2013
High RiskFDA
Specialty Compounding, Llc
All products, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613
Drugs·0 affected·Aug 9, 2013
High RiskFDA
Varian Medical Systems, Inc.
VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL130110...
Medical Devices·3 affected·Aug 9, 2013
High RiskFDA
Sonogage Inc
Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.
Diagnostic Devices·564 affected·Aug 9, 2013
High RiskFDA
Tasty Bake Inc
Frozen dough balls are sold under brand name Winco or Tasty Bake: Item # 04018 is 17 oz wheat dough ball, Winco brand, individually wr...
Frozen Food·490 affected·Aug 8, 2013
High RiskFDA
Novartis Pharmaceuticals Corp.
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Man...
Oral Drugs·174,848 affected·Aug 8, 2013
High RiskFDA
Novartis Pharmaceuticals Corp.
Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Prod...
Oral Drugs·126,245 affected·Aug 8, 2013
High RiskFDA
Novartis Pharmaceuticals Corp.
Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured...
Oral Drugs·18,665 affected·Aug 8, 2013
High RiskFDA
Qualitest Pharmaceuticals
EFFERVESCENT POTASSIUM/CHLORIDE TABLETS, 25 meq Potassium Chloride (1865 mg), POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT T...
Oral Drugs·1,680 affected·Aug 8, 2013
High RiskFDA
Novartis Pharmaceuticals Corp.
Exforge (amlodipine and valsartan Tablets) 5/160 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Nov...
Oral Drugs·1,492,475 affected·Aug 8, 2013
High RiskFDA
Novartis Pharmaceuticals Corp.
Exforge (amlodipine and valsartan Tablets) 10/160 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: No...
Oral Drugs·611,240 affected·Aug 8, 2013
High RiskFDA
Novartis Pharmaceuticals Corp.
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. M...
Oral Drugs·328,543 affected·Aug 8, 2013
High RiskFDA
Novartis Pharmaceuticals Corp.
Exforge (amlodipine and valsartan, Tablets) 10/320 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: N...
Oral Drugs·951,109 affected·Aug 8, 2013
High RiskFDA
Novartis Pharmaceuticals Corp.
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Ma...
Oral Drugs·281,935 affected·Aug 8, 2013
High RiskFDA
Novartis Pharmaceuticals Corp.
Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuti...
Oral Drugs·139,788 affected·Aug 8, 2013
High RiskFDA
Novartis Pharmaceuticals Corp.
Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12.5 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manuf...
Oral Drugs·16,693 affected·Aug 8, 2013
High RiskFDA
Novartis Pharmaceuticals Corp.
Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. ...
Oral Drugs·46,812 affected·Aug 8, 2013
High RiskFDA
Marlex Pharmaceuticals, Inc.
Acetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, List No. 152, NDC ...
Oral Drugs·28,387 affected·Aug 8, 2013
High RiskFDA
Qualitest Pharmaceuticals
K EFFERVESCENT TABLETS, 25 meq POTASSIUM (977 mg), ORANGE FLAVORED, Potassium Bicarbonate Effervescent Tablets For Oral Solution, Rx only...
Oral Drugs·1,680 affected·Aug 8, 2013
High RiskFDA
Novartis Pharmaceuticals Corp.
Diovan (valsartan) 320 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuti...
Oral Drugs·57,881 affected·Aug 8, 2013
High RiskFDA
Novartis Pharmaceuticals Corp.
Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufa...
Oral Drugs·70,006 affected·Aug 8, 2013
High RiskFDA
Novartis Pharmaceuticals Corp.
Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Nov...
Oral Drugs·869,951 affected·Aug 8, 2013
High RiskFDA
Novartis Pharmaceuticals Corp.
Tekturna (aliskiren) Tablets 300 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Prod...
Oral Drugs·128,964 affected·Aug 8, 2013