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High RiskFDA
Lloyd Inc. Of Iowa
Lloyd Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the l...
Oral Drugs·3,844,402 affected·Apr 1, 2013
High RiskFDA
Lloyd Inc. Of Iowa
Lloyd Thyro-Tab 0.175 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the l...
Oral Drugs·5,768,782 affected·Apr 1, 2013
High RiskFDA
Lloyd Inc. Of Iowa
Levothroid (levothyroxine sodium tablets, USP), 175 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, S...
Oral Drugs·32,345 affected·Apr 1, 2013
High RiskFDA
Lloyd Inc. Of Iowa
Lloyd Thyro-Tab 0.200 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the l...
Oral Drugs·5,771,989 affected·Apr 1, 2013
High RiskFDA
Fresenius Medical Care Holdings, Inc. Dba Renal Solutions
2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hem...
Medical Devices·132 affected·Apr 1, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine ...
Diagnostic Devices·478 affected·Apr 1, 2013
High RiskFDA
Roche Molecular Systems, Inc.
cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.
Medical Devices·425 affected·Apr 1, 2013
High RiskFDA
American Optisurgical Inc
American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.
Surgical Devices·194 affected·Mar 30, 2013
High RiskFDA
All One, Inc.
all One Active Senior Multiple Vitamin & Mineral Powder dietary supplement, 30 Day Supply, 15.9 oz. canisters
Supplements·796 affected·Mar 28, 2013
High RiskFDA
All One, Inc.
all One Original Formula Multiple Vitamin & Mineral Powder dietary supplement, 30 Day Supply, 15.9 oz. canisters
Baby Food & Formula·1,205 affected·Mar 28, 2013
High RiskFDA
Pfizer Inc.
Levoxyl (levothyroxine sodium) tablets, USP 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles ( NDC ...
Oral Drugs·37,809 affected·Mar 28, 2013
High RiskFDA
Pfizer Inc.
Levoxyl (levothyroxine sodium) tablets, USP 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles ( NDC ...
Oral Drugs·36,045 affected·Mar 28, 2013
High RiskFDA
Pfizer Inc.
Levoxyl (levothyroxine sodium) tablets, USP 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles ( NDC 6...
Oral Drugs·26,447 affected·Mar 28, 2013
High RiskFDA
Pfizer Inc.
Levoxyl (levothyroxine sodium) tablets, USP 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles ( NDC...
Oral Drugs·37,891 affected·Mar 28, 2013
High RiskFDA
Pfizer Inc.
Levoxyl (levothyroxine sodium) tablets, USP 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles ( NDC 6...
Oral Drugs·23,210 affected·Mar 28, 2013
High RiskFDA
Nuvision Pharmacy, Inc.
Methylcobalamin (Buffered) Injection,1 mg/mL, 30 mL vial, Stock# 11126, Preservative Free, Compounded by NuVision Pharmacy, Inc., Dallas...
Injectable Drugs·32 affected·Mar 28, 2013
High RiskFDA
Pfizer Inc.
Levoxyl (levothyroxine sodium) tablets, USP 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles ( NDC ...
Oral Drugs·18,195 affected·Mar 28, 2013
High RiskFDA
Pfizer Inc.
Levoxyl (levothyroxine sodium) tablets, USP 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles ( NDC 6...
Oral Drugs·29,613 affected·Mar 28, 2013
High RiskFDA
Pfizer Inc.
Levoxyl (levothyroxine sodium) tablets, USP 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles ( NDC ...
Oral Drugs·9,213 affected·Mar 28, 2013
High RiskFDA
Pfizer Inc.
Levoxyl (levothyroxine sodium) tablets, USP 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles ( NDC ...
Oral Drugs·7,901 affected·Mar 28, 2013
High RiskFDA
Pfizer Inc.
Levoxyl (levothyroxine sodium) tablets, USP 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles ( NDC ...
Oral Drugs·10,121 affected·Mar 28, 2013
High RiskFDA
Pfizer Inc.
Levoxyl (levothyroxine sodium) tablets, USP 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles ( NDC ...
Oral Drugs·14,464 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended...
Medical Devices·31,940 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended...
Medical Devices·19,030 affected·Mar 28, 2013
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Locking Plate System is designed to treat periarticular or intr...
Medical Devices·107 affected·Mar 28, 2013
High RiskFDA
Baxter Healthcare Corp.
A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Produ...
Surgical Devices·2 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
BioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ Extend" Absorbable Collagen Membrane is an absorbable, implantable material tha...
Medical Implants·20,032 affected·Mar 28, 2013
High RiskFDA
Baxter Healthcare Corp.
A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use...
Surgical Devices·2 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (other than ophthalmological and urologica...
Surgical Devices·14 affected·Mar 28, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter for difficult transfer with Stylet PPS623 Sure-Pro¿ Embryo Replacement Cathet...
Surgical Devices·4,910 affected·Mar 28, 2013
High RiskFDA
Ge Healthcare, Llc
MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and obliq...
Diagnostic Devices·70 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
OraMem Absorbable Collagen Membrane OraMem¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for ...
Medical Implants·812 affected·Mar 28, 2013
High RiskFDA
Advanced Sterilization Products
EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submer...
Medical Devices·761 affected·Mar 28, 2013
High RiskFDA
Ge Healthcare, Llc
Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee...
Medical Devices·81 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects. DuraGe...
Medical Implants·52 affected·Mar 28, 2013
High RiskFDA
Transonic Systems Inc
HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. ...
Cardiac Devices·195 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has be...
Medical Devices·954 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
BioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated fo...
Medical Implants·32,446 affected·Mar 28, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Obturator Product Code: PEB623 Sure-Pro¿ Embryo Replacement Catheters are us...
Surgical Devices·59,089 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for th...
Medical Implants·215 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieve...
Medical Devices·1,661 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
Absorbable Collagen Sponge Provided As Intermediate to Another Company
Medical Devices·84,460 affected·Mar 28, 2013
High RiskFDA
Baxter Healthcare Corp.
A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7", Vol. 1.10 mL, Luer Activated Valve for ...
Surgical Devices·2 affected·Mar 28, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product Code: PE623 Sure-Pro¿ Embryo Replacement Cat...
Surgical Devices·22,380 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intende...
Medical Devices·32,790 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to han...
Medical Implants·15,607 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended ...
Medical Devices·17,110 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dur...
Medical Implants·21,179 affected·Mar 28, 2013