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High RiskFDA
Pharmedium Services, Llc
VANCOMYCIN HCl 1.5g in 300 mL 5% Dextrose Injection USP, Service Code 2K2227, NDC# 61553-027-34, Total Volume 300.00 mL incorrectly label...
Injectable Drugs·108 affected·Feb 17, 2017
High RiskFDA
Pharmedium Services, Llc
VANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2237, NDC# 61553-037-34, Total Volume 300.00 mL incorre...
Injectable Drugs·60 affected·Feb 17, 2017
High RiskFDA
Pharmedium Services, Llc
Potassium PHOSphate in 0.5% Dextrose, 7.5 mMol in 100 mL, Service Code 2K5299, NDC# 61553-0299-48, Total Volume 100.00 mL incorrectly lab...
Drugs·144 affected·Feb 17, 2017
High RiskFDA
Pharmedium Services, Llc
VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2243, NDC# 61553-043-34, Total Volume 300.00 mL incorrec...
Injectable Drugs·816 affected·Feb 17, 2017
High RiskFDA
Zimmer Biomet, Inc.
various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement
Medical Implants·28,253 affected·Feb 17, 2017
High RiskFDA
Zimmer Biomet, Inc.
various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Kn...
Medical Implants·28,253 affected·Feb 17, 2017
High RiskFDA
Zimmer Biomet, Inc.
various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality component...
Medical Implants·28,253 affected·Feb 17, 2017
High RiskFDA
Zimmer Biomet, Inc.
various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delt...
Medical Implants·28,253 affected·Feb 17, 2017
High RiskFDA
Zimmer Biomet, Inc.
various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder System; Comprehensi...
Medical Implants·28,253 affected·Feb 17, 2017
High RiskFDA
Dukarani Food Processing, Inc
Pepper Sauce, Fish and Vita, Net Weight: 8 oz. Packed by: Dukarani Food Processing, Inc., 1729 Lyndale Ave. north, Mpls, MN 55411. S...
Seafood·158 affected·Feb 16, 2017
High RiskFDA
Box Mill Farm
Box Mill Farm Pasteurized Apple Cider in 1 gallon containers and Half-Gallon containers
Food·250 affected·Feb 16, 2017
High RiskFDA
Dukarani Food Processing, Inc
Benniseed, Natural sesame seeds, Vita and fish, Net Weight: 8 oz. Packed by: Dukarani Food Processing, Inc., 1729 Lyndale Ave. North, ...
Seafood·158 affected·Feb 16, 2017
High RiskFDA
Dukarani Food Processing, Inc
Ketele Sauce, Fish and Vita, Net Weight: 8 oz. Packed by: Dukarani Food Processing, Inc., 1729 Lyndale Ave. North, Mpls, MN 55411. S...
Seafood·158 affected·Feb 16, 2017
High RiskFDA
Allegiant Health
HealthA2Z CHEWABLE Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable Tablets, a) packaged in 36-count bottle [UPC Code 369168288362 (FP05...
Oral Drugs·70,176 affected·Feb 16, 2017
High RiskFDA
Sato Pharmaceutical Inc.
Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. ...
Ophthalmic Drugs·10,130 affected·Feb 16, 2017
High RiskFDA
Sato Pharmaceutical Inc.
DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5...
Drugs·14,325 affected·Feb 16, 2017
High RiskFDA
Sato Pharmaceutical Inc.
SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuti...
Ophthalmic Drugs·4,790 affected·Feb 16, 2017
High RiskFDA
Datascope Corporation
Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are...
Cardiac Devices·21 affected·Feb 16, 2017
High RiskFDA
Crossroads Extremity Systems Llc
MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.
Medical Devices·20 affected·Feb 16, 2017
High RiskFDA
Avkare Inc.
Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 502...
Oral Drugs·116 affected·Feb 15, 2017
High RiskFDA
Focus Diagnostics Inc
Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella p...
Medical Devices·1,400 affected·Feb 15, 2017
High RiskFDA
Intromedic Co., Ltd.
Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualization of the sm...
Medical Devices·82 affected·Feb 15, 2017
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous Renal Replacement Therapy (C...
Medical Devices·3,440 affected·Feb 15, 2017
High RiskFDA
Greatbatch Medical
Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). The MobiCath Bi-Direct...
Surgical Devices·11,360 affected·Feb 15, 2017
High RiskFDA
Index Fresh
Hass Avocado HA LTP S 40 1 Index Fresh- USA Hass Avocado HA LTP S 70 1 Index Fresh- USA Hass Avocado HA LTP S 70 1 Index Fresh- USA
Food·116 affected·Feb 14, 2017
High RiskFDA
Index Fresh
Hass Avocado HA LB Signature Farms 15/4 60 1- USA Hass Avocado HA LTP S 60 1 Index Fresh- USA Hass Avocado HA RPCFB 10/4 70 1 Index Fre...
Food·176 affected·Feb 14, 2017
High RiskFDA
Index Fresh
Hass Avocado 32 1 Index Fresh- USA Hass Avocado 36 1 Index Fresh- USA Hass Avocado 40 1 Index Fresh- USA Hass Avocado 48 1 Index Fresh...
Food·6 affected·Feb 14, 2017
High RiskFDA
Zimmer Biomet, Inc.
Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.
Medical Devices·3,232 affected·Feb 14, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
ONCOR" Avant-garde
Medical Devices·80 affected·Feb 14, 2017
High RiskFDA
Euro Diagnostica Ab
Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides pre...
Diagnostic Devices·534 affected·Feb 14, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
ONCOR" Expression ONCOR" Impression ONCOR" Impression plus
Medical Devices·80 affected·Feb 14, 2017
High RiskFDA
Nu Skin Enterprises Inc.
Pharmanex Cortitrol. Cortisol Management. 60 Capsules
Food·56,332 affected·Feb 13, 2017
High RiskFDA
World Organic Corp.
Theravits 100, container sizes: 30, 60, 90, 180, Product Code: 0783-30, 0786-60, 0789-90, 0788-180; The Supreme One, Container sizes:...
Food·54,262 affected·Feb 13, 2017
High RiskFDA
Nu Skin Enterprises Inc.
Pharmanex Cholestin. Cholesterol Health. 60 Softgels.
Food·7,327 affected·Feb 13, 2017
High RiskFDA
Nu Skin Enterprises Inc.
Pharmanex BioGinkgo. Mental Sharpness. 60 Tablets
Food·40,158 affected·Feb 13, 2017
High RiskFDA
Mccormick & Co Inc. Spice Mill Plant
McCormick & Co., Inc., Stubbs Barbecue. 18oz Best By Date of January 17, 2020.
Food·583 affected·Feb 13, 2017
High RiskFDA
Abbott Laboratories
CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a multi-parameter automated hematology analyze...
Diagnostic Devices·116 affected·Feb 13, 2017
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The Beckman Coulter AU680 and the AU5800 Clinic...
Diagnostic Devices·2 affected·Feb 13, 2017
High RiskFDA
Country Fresh Inc.
Country Fresh Creations Stuffed Mushrooms Net Wt. 7 oz. (198g) Packed Regionally by Country Fresh LLC Headquarters, Conroe, TX 77384 www....
Food·165 affected·Feb 10, 2017
High RiskFDA
Country Fresh Inc.
Country Fresh Creations Tuscan Style Portabella Mushrooms Net Wt. 8oz (227g) Distributed by Country Fresh, LLC., Houston, TX 77090 UPC: 0...
Food·236 affected·Feb 10, 2017
High RiskFDA
Country Fresh Inc.
Marketside Garlic & Four Cheese Stuffed Baby Bellas Net Wt. 7 oz. (198g) Distributed By: Wal-Mart Stores, Inc., Bentonville, AR 72716 UPC...
Dairy·301 affected·Feb 10, 2017
High RiskFDA
Del Monte Fresh Produce N.a., Inc. Hq
Choice Farms Pizza Style Portabella Mushrooms 8 oz. INDIVIDUAL SHRINK-WRAPPED TRAYS
Food·124 affected·Feb 10, 2017
High RiskFDA
Synergy Rx
REVERSE DML LOTION (Ketoconazole 2%, Metronidazole 2%, sulfacetamide sodium 10%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego...
Drugs·0 affected·Feb 10, 2017
High RiskFDA
Synergy Rx
LP CREAM (Lidocaine 15%/Prilocaine 5%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Topical Drugs·0 affected·Feb 10, 2017
High RiskFDA
Synergy Rx
CUSTOM LIGHTENING/BRIGHTENING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Topical Drugs·0 affected·Feb 10, 2017
High RiskFDA
Synergy Rx
TRI-BLEACHING CREAM (Retinoic Acid 0.1%, Hydroquinone 4%, Fluocinolone 0.01%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, C...
Topical Drugs·0 affected·Feb 10, 2017
High RiskFDA
Synergy Rx
HYDROCORTISONE 2.5% WITH ALOE VERA CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Topical Drugs·0 affected·Feb 10, 2017
High RiskFDA
Synergy Rx
CLOBETASOL 0.05% IN OLEA BASE, CLOBETASOL 0.05% IN OROBASE, CLOBETASOL 0.05% OINTMENT, CLOBETASOL 0.05%/ SODIUM, SULFACETAMIDE 10% CREAM,...
Topical Drugs·0 affected·Feb 10, 2017