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High RiskFDA
Sca Pharmaceuticals
fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl D...
Injectable Drugs·370 affected·May 18, 2017
High RiskFDA
Sca Pharmaceuticals
MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) S...
Injectable Drugs·40 affected·May 18, 2017
High RiskFDA
Sca Pharmaceuticals
fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl D...
Injectable Drugs·118 affected·May 18, 2017
High RiskFDA
Sca Pharmaceuticals
morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 10...
Injectable Drugs·80 affected·May 18, 2017
High RiskFDA
Sca Pharmaceuticals
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g, Total Approximate Volume 115 mL, Single Dose Container bag, Preser...
Injectable Drugs·70 affected·May 18, 2017
High RiskFDA
Sca Pharmaceuticals
PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Contai...
Injectable Drugs·30 affected·May 18, 2017
High RiskFDA
Forest Laboratories, Llc
Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx only, Black Cherry Flavor, Manufactured by: Catalent UK Swindo...
Oral Drugs·40,621 affected·May 18, 2017
High RiskFDA
Sca Pharmaceuticals
fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg per mL, Single Dose Container bag, (Total fentanyl Dose 2,000 mcg/1...
Injectable Drugs·100 affected·May 18, 2017
High RiskFDA
Brightfarms, Inc.: Wdc Greenhouse Llc
Bright Farms Baby Kale 3 oz. package , The salad products packaged in clear, plastic clamshells with best by dates on the package .
Produce·547 affected·May 17, 2017
High RiskFDA
Brightfarms, Inc.: Wdc Greenhouse Llc
Bright Farms Spinach Blend (4 oz. package) , The salad products packaged in clear, plastic clamshells with best by dates on the package .
Produce·392 affected·May 17, 2017
High RiskFDA
Brightfarms, Inc.: Wdc Greenhouse Llc
Bright Farms Spring Mix (4 oz. and 8 oz. package) , The salad products packaged in clear, plastic clamshells with best by dates on the pa...
Produce·1,598 affected·May 17, 2017
High RiskFDA
Brightfarms, Inc.: Wdc Greenhouse Llc
Bright Farms LEMON BASIL 0.75oz package , The salad products packaged in clear, plastic clamshells with best by dates on the package .
Produce·20 affected·May 17, 2017
High RiskFDA
Brightfarms, Inc.: Wdc Greenhouse Llc
Bright Farms Mixed Greens 4oz package , The salad products packaged in clear, plastic clamshells with best by dates on the package .
Produce·555 affected·May 17, 2017
High RiskFDA
Brightfarms, Inc.: Wdc Greenhouse Llc
Bright Farms Baby Spinach (4 oz. package) The salad products packaged in clear, plastic clamshells with best by dates on the package .
Produce·346 affected·May 17, 2017
High RiskFDA
Brightfarms, Inc.: Wdc Greenhouse Llc
Bright Farms Arugula (4 oz. and 8 oz. package) (4 oz. and 8 oz. package) , The salad products packaged in clear, plastic clamshells with ...
Produce·664 affected·May 17, 2017
High RiskFDA
Brightfarms, Inc.: Wdc Greenhouse Llc
Bright Farms Baby Romaine - 4oz package , The salad products packaged in clear, plastic clamshells with best by dates on the package .
Produce·300 affected·May 17, 2017
High RiskFDA
Brightfarms, Inc.: Wdc Greenhouse Llc
Bright Farms Thai Basil 0.75oz package , The salad products packaged in clear, plastic clamshells with best by dates on the package .
Produce·20 affected·May 17, 2017
High RiskFDA
Brightfarms, Inc.: Wdc Greenhouse Llc
Bright Farms Basil (.75 oz. package) The salad products packaged in clear, plastic clamshells with best by dates on the package .
Produce·75 affected·May 17, 2017
High RiskFDA
X-gen Pharmaceuticals Inc.
Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61
Topical Drugs·9,816 affected·May 17, 2017
High RiskFDA
Vistapharm, Inc.
Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individ...
Oral Drugs·2,208,500 affected·May 17, 2017
High RiskFDA
Medtronic Sofamor Danek Usa Inc
KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
Medical Devices·17,657 affected·May 17, 2017
High RiskFDA
Z-medica, Llc
QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fair...
Surgical Devices·2,910 affected·May 17, 2017
High RiskFDA
Biosense Webster, Inc.
PENTARAY NAV High-Density Mapping Catheter.
Surgical Devices·73,796 affected·May 17, 2017
High RiskFDA
Prosupps Usa Llc
Mr. Hyde Blue Razz (V2)
Food·34,124 affected·May 16, 2017
High RiskFDA
Prosupps Usa Llc
Mr. Hyde Watermelon (V2); Mr. Hyde 30 Watermelon
Beverages·22,561 affected·May 16, 2017
High RiskFDA
Prosupps Usa Llc
Dr. Jekyll V2 Orange Burst domestic
Food·698 affected·May 16, 2017
High RiskFDA
Prosupps Usa Llc
Dr. Jekyll V2 Watermelon domestic
Beverages·6,348 affected·May 16, 2017
High RiskFDA
Prosupps Usa Llc
Mr. Hyde, Fruit Punch, 30 servings; Mr. Hyde Fruit Punch (V2); Mr. Hyde 30 INT'L Fruit Punch; Mr. Hyde Fruit Punch RTD; Mr. Hyde V2 domes...
Produce·37,983 affected·May 16, 2017
High RiskFDA
Prosupps Usa Llc
Dr. Jekyll 30 Fruit Punch
Produce·3,957 affected·May 16, 2017
High RiskFDA
Prosupps Usa Llc
Dr. Jekyll V2 Green Apple International
Food·3,045 affected·May 16, 2017
High RiskFDA
Prosupps Usa Llc
Mr. Hyde Green Apple; Mr. Hyde Green Apple Sweden
Food·28,045 affected·May 16, 2017
High RiskFDA
Glaxosmithkline, Llc
Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKli...
Inhaled / Nasal Drugs·562,883 affected·May 16, 2017
High RiskFDA
Exactech, Inc.
Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by...
Medical Devices·9 affected·May 16, 2017
High RiskFDA
Biomerieux Inc
VITEK 2 Gram Negative test kits containing colistin (cs01n)
Diagnostic Devices·1,520,000 affected·May 16, 2017
High RiskFDA
Exactech, Inc.
Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with ankle joints damage...
Medical Devices·9 affected·May 16, 2017
High RiskFDA
Baxter Healthcare Corporation
Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporati...
Injectable Drugs·90,450 affected·May 15, 2017
High RiskFDA
Baxter Healthcare Corporation
Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, De...
Injectable Drugs·113,590 affected·May 15, 2017
High RiskFDA
Perkinelmer Life Sciences, Inc.
Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Mu...
Medical Devices·241 affected·May 15, 2017
High RiskFDA
Beckman Coulter Inc
Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea,...
Diabetes Devices·4,444 affected·May 15, 2017
High RiskFDA
Biomerieux, Inc.
VIDAS Testosterone, Ref 30418
Medical Devices·742 affected·May 15, 2017
High RiskFDA
Boston Scientific Corporation
FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devi...
Medical Devices·3 affected·May 15, 2017
High RiskFDA
Sabor Mexicano
Sabor Mexicano Homemade Corn Chips: Packaged in 12 oz. (9 units per case), UPC 8-53094-00417-7, and Fun size 5 oz. ( 12 units per cas...
Snacks & Candy·4,959 affected·May 14, 2017
High RiskFDA
New Punjab Sweets Inc.
New Punjab Sweets, Jalebi
Food·36 affected·May 12, 2017
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw set is intended to ...
Medical Devices·115 affected·May 12, 2017
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is intended to trea...
Medical Devices·184 affected·May 12, 2017
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat ...
Medical Devices·153 affected·May 12, 2017
High RiskFDA
Terumo Cardiovascular Systems Corp
Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmo...
Medical Devices·30 affected·May 12, 2017
High RiskFDA
Trident Seafoods Corp - Island Enterprise M/v
Trident Item # 38520, Panko Breaded Alaska Cod, 4 oz. Square Portions Raw, Food Service packages, frozen, Net Wt. 10 lbs.
Bakery & Grains·432 affected·May 11, 2017