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High RiskFDA
Nuevotanicals
Kr8om Max2 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112, 2 tablets; Kr8om Max5 All-Na...
Baby Food & Formula·2,066 affected·Jul 1, 2014
High RiskFDA
Nuevotanicals
100% NATURAL HERBAL MIND & BODY SHOT greenjoy Sustained, Relaxed Energy Supports Mood & Immune Functions Relief of pain for aging bo...
Baby Food & Formula·0 affected·Jul 1, 2014
High RiskFDA
Purefruit Chile S.a
fruty U applesauce, apple; 3.5 oz/20 pk applesauce is packed into a labeled aluminum pouch with plastic screw-on lid and then placed into...
Food·63,958 affected·Jul 1, 2014
High RiskFDA
Nuevotanicals
Kratom (Kr8om) Premium Bali Alkaloid Suspension Oil in 135 mg., 200 mg., and 300 mg. dosages and Kratom (KR8om) Bali Custom Alkaloid Susp...
Food·52,552 affected·Jul 1, 2014
High RiskFDA
Nuevotanicals
Green Malay/MD bulk in 1 gallon plastic jugs, no product label
Food·77 affected·Jul 1, 2014
High RiskFDA
Purefruit Chile S.a
Market Pantry Apple; 3.5 oz/12 pk applesauce is packed into a labeled aluminum pouch with plastic screw-on lid and then placed into a lab...
Produce·63,958 affected·Jul 1, 2014
High RiskFDA
Nuevotanicals
Kratom (Kr8om) Maeng Da Thai Pure Alkaloid Suspension Oil in 150 mg,
Food·1,800 affected·Jul 1, 2014
High RiskFDA
Nuevotanicals
Enhanced Leaf Powder in Ziploc-type freezer bags in 500 g increments, no product label; Bulk Raw (non-extracted) Kratom Leaf Powder in Zi...
Food·71 affected·Jul 1, 2014
High RiskFDA
Purefruit Chile S.a
fruty U applesauce, apple cinnamon; 3.5 oz/20 pk applesauce is packed into a labeled aluminum pouch with plastic screw-on lid and then pl...
Food·63,958 affected·Jul 1, 2014
High RiskFDA
Purefruit Chile S.a
Market Pantry Apple Cinnamon; 3.5 oz/12 pk applesauce is packed into a labeled aluminum pouch with plastic screw-on lid and then placed i...
Produce·63,958 affected·Jul 1, 2014
High RiskFDA
Nuevotanicals
Kratom (Kr8om) MD (Maeng Da Thai) Oil in 225 mg., 375 mg., and 150 mg. dosages.
Food·34,337 affected·Jul 1, 2014
High RiskFDA
Zimmer, Inc.
PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to...
Medical Implants·190 affected·Jul 1, 2014
High RiskFDA
Zimmer, Inc.
PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to...
Medical Implants·190 affected·Jul 1, 2014
High RiskFDA
Perkinelmer Health Sciences, Inc.
Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is ext...
Medical Devices·144 affected·Jul 1, 2014
High RiskFDA
Zimmer, Inc.
Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 203 mm Length. Product Usage: The Moore Hip Prosthesis is...
Medical Implants·68 affected·Jul 1, 2014
High RiskFDA
Biogenex Laboratories, Inc.
InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
Diagnostic Devices·4 affected·Jul 1, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to ...
Medical Devices·141 affected·Jun 30, 2014
High RiskFDA
Teleflex Medical
RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed by: Teleflex Medical.
Medical Devices·6,246 affected·Jun 30, 2014
High RiskFDA
Healix Infusion Therapy, Inc.
fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--N...
Drugs·0 affected·Jun 27, 2014
High RiskFDA
Healix Infusion Therapy, Inc.
fentaNYL 1500 mcg/30 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Feder...
Drugs·50 affected·Jun 27, 2014
High RiskFDA
Healix Infusion Therapy, Inc.
fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not...
Drugs·48 affected·Jun 27, 2014
High RiskFDA
Healix Infusion Therapy, Inc.
fentaNYL 2750 mcg/55 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG, For Institutional or Office Use Only--Not for Resale Feder...
Drugs·220 affected·Jun 27, 2014
High RiskFDA
Healix Infusion Therapy, Inc.
fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chloride 100mL, in flexable bag, COMPOUNDED DRUG For Institutio...
Drugs·12 affected·Jun 27, 2014
High RiskFDA
Hospira Inc.
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lak...
Injectable Drugs·47,400 affected·Jun 27, 2014
High RiskFDA
Brainlab Ag
Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the dis...
Medical Devices·154 affected·Jun 27, 2014
High RiskFDA
Perkinelmer Health Sciences, Inc.
PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is in...
Medical Devices·13 affected·Jun 27, 2014
High RiskFDA
Life Force Of Tampa, Llc
Life Force Chamber Product Usage:The product is intended for restful contemplation and spirituality.
Medical Devices·10 affected·Jun 27, 2014
High RiskFDA
Integra Lifesciences Corp.
Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP (NewPort Instrument Tray w/ Compo...
Medical Implants·4 affected·Jun 27, 2014
High RiskFDA
Steris Corporation
The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all gen...
Surgical Devices·3,689 affected·Jun 27, 2014
High RiskFDA
Caraco Pharmaceutical Laboratories, Ltd.
Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx onl...
Oral Drugs·70,152 affected·Jun 26, 2014
High RiskFDA
Caraco Pharmaceutical Laboratories, Ltd.
Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx onl...
Oral Drugs·43,585 affected·Jun 26, 2014
High RiskFDA
Hill-rom, Inc.
Affinity¿ Four Birthing Bed, Product Usage: Product is intended to be used as birthing beds for women of child bearing age in an LDR...
Medical Devices·13,000 affected·Jun 26, 2014
High RiskFDA
Biosound Esaote, Inc.
Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging
Medical Devices·1,301 affected·Jun 26, 2014
High RiskFDA
Alphatec Spine, Inc.
Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, a spinal fixation...
Medical Devices·14 affected·Jun 26, 2014
High RiskFDA
Manufacturing Solutions International
Cool Tropics Rips Slush, Blue Raspberry Flavored 100% Juice No artificial colors or flavors, Juice from Concentrate 4 fl oz, (118 mL), Co...
Beverages·259 affected·Jun 25, 2014
High RiskFDA
Manufacturing Solutions International
Cool Tropics Rips Slush, Sour Apple Flavored 100% Juice No artificial colors or flavors, Juice from Concentrate 4 fl oz, (118 mL), Contai...
Beverages·502 affected·Jun 25, 2014
High RiskFDA
Manufacturing Solutions International
Cool Tropics Rips Slush, Cherry LimeadeFlavored 100% Juice No artificial colors or flavors, Juice from Concentrate 4 fl oz, (118 mL),Manu...
Beverages·80 affected·Jun 25, 2014
High RiskFDA
Medical Supply Liquidators Llc
G.A.C. 375 Injection USP, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunsh...
Injectable Drugs·0 affected·Jun 25, 2014
High RiskFDA
Medical Supply Liquidators Llc
Vitamin B12 Hydroxocobalamin Injection USP 1000 mcg/ml, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: ...
Injectable Drugs·0 affected·Jun 25, 2014
High RiskFDA
Medical Supply Liquidators Llc
BCAA 4% Branched Chain Amino Acid Injection USP, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc....
Injectable Drugs·0 affected·Jun 25, 2014
High RiskFDA
Medical Supply Liquidators Llc
Glutathione Injection USP, 200 mg/ml, packaged in 30 ml vials, Sterile, For IM of Deep SQ Use, Multiple Dose Vial, Manufactured by: CB In...
Injectable Drugs·0 affected·Jun 25, 2014
High RiskFDA
Medical Supply Liquidators Llc
Vitamin B12 Methylcobalamin 5000 Injection USP 5000 mcg/ml, 10 ml vial and 30 ml vial, Sterile, for IM or Deep SQ Use, Multiple Dose Vial...
Injectable Drugs·0 affected·Jun 25, 2014
High RiskFDA
Medical Supply Liquidators Llc
L-Carnitine Injection USP 100 mg/ml, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc...
Injectable Drugs·0 affected·Jun 25, 2014
High RiskFDA
Medical Supply Liquidators Llc
Super MIC B Complex for L-Carnitine for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose Via...
Injectable Drugs·0 affected·Jun 25, 2014
High RiskFDA
Medical Supply Liquidators Llc
Vitamin B12 Methylcobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial, Man...
Injectable Drugs·0 affected·Jun 25, 2014
High RiskFDA
Medical Supply Liquidators Llc
B Complex for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ use, multiple dose vial, packaged in 10 ml vials...
Injectable Drugs·0 affected·Jun 25, 2014
High RiskFDA
Medical Supply Liquidators Llc
MIC Injection USP, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine L...
Injectable Drugs·0 affected·Jun 25, 2014
High RiskFDA
Medical Supply Liquidators Llc
Vitamin B12 Cyanocobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manu...
Injectable Drugs·0 affected·Jun 25, 2014