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High RiskFDA
Franck's Lab Inc Dba Trinity Care Solutions
Invanz (ertapenem)1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # ...
Drugs·12 affected·May 15, 2014
High RiskFDA
Franck's Lab Inc Dba Trinity Care Solutions
Tobramycin 300 mg/7.5 mL Syringe (for Neb), Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, ...
Drugs·14 affected·May 15, 2014
High RiskFDA
Franck's Lab Inc Dba Trinity Care Solutions
Vancomycin 1.25 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29185...
Drugs·14 affected·May 15, 2014
High RiskFDA
Franck's Lab Inc Dba Trinity Care Solutions
Cefazolin 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28837, Di...
Drugs·21 affected·May 15, 2014
High RiskFDA
Franck's Lab Inc Dba Trinity Care Solutions
Vancomycin 1 gm/100 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29186, Di...
Drugs·21 affected·May 15, 2014
High RiskFDA
Franck's Lab Inc Dba Trinity Care Solutions
Cefepime 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28879, Dis...
Drugs·11 affected·May 15, 2014
High RiskFDA
Franck's Lab Inc Dba Trinity Care Solutions
Ceftriaxone 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29150, Dis...
Drugs·5 affected·May 15, 2014
High RiskFDA
Bacterin International, Inc.
Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different sizes, 10 units per box: 19...
Respiratory Devices·390 affected·May 15, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Ad...
Diagnostic Devices·5 affected·May 15, 2014
High RiskFDA
Boston Scientific Corporation
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. The BSC Controller and Accessories are indicated for...
Cardiac Devices·968 affected·May 15, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height A...
Diagnostic Devices·420 affected·May 15, 2014
High RiskFDA
Boston Scientific Corporation
IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated f...
Cardiac Devices·968 affected·May 15, 2014
High RiskFDA
Boston Scientific Corporation
IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetric Curve. The BSC Controller and Accessories are indicated...
Cardiac Devices·968 affected·May 15, 2014
High RiskFDA
Ebi, Llc
Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
Medical Devices·32 affected·May 15, 2014
High RiskFDA
Synthes, Inc.
Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instr...
Surgical Devices·44 affected·May 15, 2014
High RiskFDA
Boston Scientific Corporation
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated f...
Cardiac Devices·968 affected·May 15, 2014
High RiskFDA
Nxstage Medical, Inc.
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-302 Lactate , 40, Potassium 1, Sodium 140, Calcium 3, ...
Diabetes Devices·19,423 affected·May 14, 2014
High RiskFDA
Nxstage Medical, Inc.
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-305 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Ma...
Diabetes Devices·2,839 affected·May 14, 2014
High RiskFDA
Beckman Coulter, Inc.
MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34 Neg panels are designed for ...
Medical Devices·681 affected·May 14, 2014
High RiskFDA
Beckman Coulter Inc.
Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay Systems includes...
Diagnostic Devices·82 affected·May 14, 2014
High RiskFDA
Nxstage Medical, Inc.
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-304 Lactate 45, Potassium 2, Sodium 140, Calcium 3,Mag...
Diabetes Devices·16,625 affected·May 14, 2014
High RiskFDA
Amo Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of ap...
Medical Implants·77,055 affected·May 13, 2014
High RiskFDA
Amo Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of ap...
Medical Implants·77,055 affected·May 13, 2014
High RiskFDA
Amo Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of ap...
Medical Implants·77,055 affected·May 13, 2014
High RiskFDA
Amo Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of ap...
Medical Implants·77,055 affected·May 13, 2014
High RiskFDA
Amo Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of ap...
Medical Implants·77,055 affected·May 13, 2014
High RiskFDA
Amo Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of ap...
Medical Implants·77,055 affected·May 13, 2014
High RiskFDA
Amo Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of ap...
Medical Implants·77,055 affected·May 13, 2014
High RiskFDA
Amo Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of ap...
Medical Implants·77,055 affected·May 13, 2014
High RiskFDA
Amo Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of ap...
Medical Implants·77,055 affected·May 13, 2014
High RiskFDA
Amo Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of ap...
Medical Implants·77,055 affected·May 13, 2014
High RiskFDA
Amo Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of ap...
Medical Implants·77,055 affected·May 13, 2014
High RiskFDA
Coopersurgical, Inc.
Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
Surgical Devices·1,180 affected·May 13, 2014
High RiskFDA
Amo Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of ap...
Medical Implants·77,055 affected·May 13, 2014
High RiskFDA
Amo Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of ap...
Medical Implants·77,055 affected·May 13, 2014
High RiskFDA
Kerry Foods
Kerry 52-0189-02 All Purpose Beef & Chicken Meatball Seasoning, Net WT 43.42 lbs (19.69 Kg) , B18517.01.
Meat & Poultry·8,727 affected·May 12, 2014
High RiskFDA
Kerry Foods
Kerry 52-0197-02, , Net Wt 39.7 lbs (18.00 Kg), B18516.01.
Food·12,548 affected·May 12, 2014
High RiskFDA
John W Hollis Inc
Polidocanol 1% Solution for Injection, each mL contains Polidocanol (Laureth 9) 10 mg, also contains Sterile Water for Injection, Ethyl A...
Injectable Drugs·100 affected·May 12, 2014
High RiskFDA
John W Hollis Inc
Polidocanol 0.5% Solution for Injection, Polidocanol (Laureth 9) 5mg, 50 mL, JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, T...
Injectable Drugs·300 affected·May 12, 2014
High RiskFDA
Forest Pharmaceuticals Inc
Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed from Mylan Laboratories Inc., Under license from Janssen Pha...
Oral Drugs·21,875 affected·May 12, 2014
High RiskFDA
John W Hollis Inc
Mannitol 5% Solution for injection, Mannitol 50 mg, also contains Sterile Water for Injection, Chlorobutanol USP, 50 mL, JOHN HOLLIS Phar...
Injectable Drugs·2,250 affected·May 12, 2014
High RiskFDA
John W Hollis Inc
Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 40 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue ...
Drugs·45 affected·May 12, 2014
High RiskFDA
John W Hollis Inc
Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 20 mcg, 10 mL, JOHN HOLLIS Pharmacist, Inc 110 20th Avenue N, Nashville, TN...
Drugs·10 affected·May 12, 2014
High RiskFDA
John W Hollis Inc
Levocarnitine Solution for injection, l-Carnitine 50 mg, Also Contains Sterile Water for Injection and Benzyl Alcohol pH adjusted with HC...
Injectable Drugs·1,750 affected·May 12, 2014
High RiskFDA
John W Hollis Inc
PYRIDOXINE HCL, Pyridoxine HCl 100mg, Also Contans: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 3...
Drugs·30 affected·May 12, 2014
High RiskFDA
John W Hollis Inc
Liver Derivative Complex for injection, each mL contains: Liver Derivative Complex 25.5mg, also contains: Water for Injection, Phenol 0.5...
Injectable Drugs·1,560 affected·May 12, 2014
High RiskFDA
John W Hollis Inc
Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 20 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue ...
Drugs·365 affected·May 12, 2014
High RiskFDA
John W Hollis Inc
Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 10 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue ...
Drugs·40 affected·May 12, 2014