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High RiskFDA
Fresenius Kabi Usa, Llc
CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, I...
Injectable Drugs·240,550 affected·Sep 27, 2012
High RiskFDA
Fresenius Kabi Usa, Llc
MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 6017...
Injectable Drugs·101,200 affected·Sep 27, 2012
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, I...
Oral Drugs·1,512 affected·Sep 27, 2012
High RiskFDA
Fresenius Kabi Usa, Llc
ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumbu...
Injectable Drugs·184,550 affected·Sep 27, 2012
High RiskFDA
Cellestis Inc
Vacuette Cellestis 1 ml QuantiFERON¿ TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413. HE0396. greiner bio-one; 13x75 50pcs.,1200 pcs...
Diagnostic Devices·29,690 affected·Sep 27, 2012
High RiskFDA
Cellestis Inc
VACUETTE Cellestis 1 ml QuantiFERON¿ - TB ANTIGEN; Shake 10x; REF 454074; HE0105; 13X75 50 pcs.,1200 pcs. in total; Product Usage: Qu...
Diagnostic Devices·309,400 affected·Sep 27, 2012
High RiskFDA
General Mills, Inc
Individual wrapper: Nature Valley Sweet & Salty Nut, granola bars, Peanut, net WT 1.2 oz (35 g) UPC 0 1600044282 5, Distributed by Genera...
Dairy·2,511 affected·Sep 26, 2012
High RiskFDA
New England Compounding Center
Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
Drugs·165 affected·Sep 26, 2012
High RiskFDA
New England Compounding Center
Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA
Drugs·7,055 affected·Sep 26, 2012
High RiskFDA
New England Compounding Center
Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England Compounding Center, Framingham, MA
Drugs·8,919 affected·Sep 26, 2012
High RiskFDA
New England Compounding Center
Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Drugs·54 affected·Sep 26, 2012
High RiskFDA
New England Compounding Center
Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compou...
Drugs·56,655 affected·Sep 26, 2012
High RiskFDA
New England Compounding Center
Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Drugs·3,321 affected·Sep 26, 2012
High RiskFDA
New England Compounding Center
Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding C...
Injectable Drugs·0 affected·Sep 26, 2012
High RiskFDA
New England Compounding Center
Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg/mL PF Injection, Betamethasone Sodium Phosphate...
Injectable Drugs·0 affected·Sep 26, 2012
High RiskFDA
New England Compounding Center
Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufactured by New England Compounding Center, Framingham, MA
Drugs·0 affected·Sep 26, 2012
High RiskFDA
New England Compounding Center
Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, Framingham, MA
Drugs·2,747 affected·Sep 26, 2012
High RiskFDA
New England Compounding Center
Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center, Framingham, MA
Drugs·0 affected·Sep 26, 2012
High RiskFDA
New England Compounding Center
Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, ...
Drugs·20 affected·Sep 26, 2012
High RiskFDA
New England Compounding Center
Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Drugs·10,865 affected·Sep 26, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Definium 5000 / 5220493 X-Ray System
Medical Devices·312 affected·Sep 26, 2012
High RiskFDA
Degotzen
DeGotzen XRay unit XGenus Dental X-ray unit.
Medical Devices·159 affected·Sep 26, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up ...
Medical Devices·26 affected·Sep 25, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass pro...
Medical Devices·289 affected·Sep 25, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass...
Medical Devices·1,076 affected·Sep 25, 2012
High RiskFDA
Belmont Instrument Corporation
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
Medical Devices·2,913 affected·Sep 25, 2012
High RiskFDA
Stryker Communications, Inc.
(l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker Flat Panel and Navigation Arm The Spring Arm Circlip is p...
Surgical Devices·1,082 affected·Sep 25, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for...
Medical Devices·312 affected·Sep 25, 2012
High RiskFDA
Teleflex Medical
Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709. Teleflex Me...
Surgical Devices·126 affected·Sep 25, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up ...
Medical Devices·274 affected·Sep 25, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up t...
Medical Devices·81 affected·Sep 25, 2012
High RiskFDA
Richmond Baking Of Georgia Inc
MJM Tropical Treats, Tropical Shaped Grahams, Orange, Net Wt. 1 oz., MJM Marketing, Super Wholesome Grahams, P.O. Box 1477, Kailua Kona, ...
Food·896 affected·Sep 24, 2012
High RiskFDA
Greatbatch Medical
Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath...
Cardiac Devices·9,040 affected·Sep 24, 2012
High RiskFDA
Mindray Ds Usa, Inc. D.b.a. Mindray North America
Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 ...
Cardiac Devices·206 affected·Sep 24, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Centrifugal System Control module System 9000 The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass proced...
Medical Devices·126 affected·Sep 24, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedur...
Medical Devices·847 affected·Sep 24, 2012
High RiskFDA
M & K Trading Inc
Seasoned Clams, 240 grams
Food·39 affected·Sep 21, 2012
High RiskFDA
Baxter Healthcare Corp.
10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; produc...
Injectable Drugs·2,976 affected·Sep 21, 2012
High RiskFDA
Baxter Healthcare Corp.
Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E2322B, NDC 0338-6307-02; b) 500 mL AVIVA Container...
Injectable Drugs·55,664 affected·Sep 21, 2012
High RiskFDA
American Enterprises Llc Dba Sterling Gelatin
Limed Bone Gelatin, packaged in six 125 kg fiber drums and labeled in part PO NO.: P8095 GELATIN 75 BLOOM ITEM NO. RM 164. MADE IN INDIA
Drugs·750 affected·Sep 21, 2012
High RiskFDA
Baxter Healthcare Corp.
5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC 0338-6346-02; b) 500 mL AVIVA Container, produ...
Injectable Drugs·753,941 affected·Sep 21, 2012
High RiskFDA
Baxter Healthcare Corp.
5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfi...
Injectable Drugs·5,064 affected·Sep 21, 2012
High RiskFDA
Baxter Healthcare Corp.
0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC 0338-6304-02; b) 500 mL AVIVA Contain...
Injectable Drugs·897,496 affected·Sep 21, 2012
High RiskFDA
Asahi Kasei Medical Co., Ltd., Okatomi Plant
Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter
Medical Devices·1,536 affected·Sep 21, 2012
High RiskFDA
Sanofi-aventis Us, Inc.
Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes.
Diabetes Devices·1,600 affected·Sep 21, 2012
High RiskFDA
Asahi Kasei Medical Co., Ltd., Okatomi Plant
Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter
Medical Devices·55,632 affected·Sep 21, 2012
High RiskFDA
Oregon Ice Cream, Llc
Alden's Cookies and Cream is an ice cream product. It is packaged in a 1.5 quart (48 oz) cup. The LID of the recalled product is labe...
Dairy·1,400 affected·Sep 20, 2012
High RiskFDA
Genentech Inc
Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0076-01
Injectable Drugs·10,306 affected·Sep 20, 2012