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High RiskFDA
Key Pharmacy And Compounding Center
TRI MIX 45.45/27.27/0.45 5ML MDV MCG/MG/MG/ML INJ, Injection, 45.45mcg/27.27mg/0.45mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepare...
Injectable Drugs·1 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
TRI MIX 40/30/2 5ML MDV MCG/MG/MG/ML INJ, Injection, 40mcg/30mg/2mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compoundi...
Injectable Drugs·2 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
FOLINIC ACID MDV INJ, Injection, 10 mg/mL, Rx only, packaged in 2mL and 10 mL glass/Multiple Dose vials, Prepared by Key Compounding Phar...
Injectable Drugs·12 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
HYDROXO-B12 PBF MDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, packaged in a 5 mL and 30 mL Glass/ Multiple Dose vials, Prepared by Key Co...
Injectable Drugs·27 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
SODIUM BICARB 50ML MDV 8.4% (2 MOSMOL/ML) INJ, Injection, 8.40%, Rx only, 5mL Glass/Multiple Dose via, Prepared by Key Compounding Phar...
Injectable Drugs·2 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
PGE1/CPZ 5ML MDV 20MCG/1MG/ML INJ, Injection, 20mcg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Injectable Drugs·2 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
METHYL-B12 5ML MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Injectable Drugs·26 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
TRI MIX 13/30/0.8 5ML MDV MCG/MG/MG/ML INJ, Injection, 13mcg/30mg/0.8mg/mL, RX only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compo...
Injectable Drugs·1 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
TRI MIX 10/30/0.5 *5ML* MDV MCG/MG/MG/ML INJ, Injection,10mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Com...
Injectable Drugs·200 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
CO-Q-10 OIL 20ML MDV (CALIF) 25MG/ML INJ, Injection, 25mg/mL, Rx only, 20mL Glass /Multiple Dose vial, Prepared by Key Compounding Phar...
Injectable Drugs·1 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
TRI MIX 6/18/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 6mcg/18mg/0.6mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compoun...
Injectable Drugs·2 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
PGE1 5ML MDV INJ, Injection, 40mcg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Injectable Drugs·2 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
VIT C/GSH 1.25%-1.25% OPHTH, Ophthalmic, 1.25%, Rx only, 15 mL Plastic/ Multiple Dose bottle, Prepared by Key Compounding Pharmacy
Ophthalmic Drugs·10 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
SODIUM CHLORIDE INH PF GV 0.9% SOLN, Inhalation Solution, 0.90%, Rx only, 5mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
Drugs·75 affected·Apr 18, 2017
High RiskFDA
Abbott Laboratories
ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determinat...
Diagnostic Devices·7,981 affected·Apr 18, 2017
High RiskFDA
Elitech Clinical Systems Sas
ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Cata...
Medical Devices·0 affected·Apr 18, 2017
High RiskFDA
Moondance Heavenly Desserts, Llc
Moondance desserts gluten free Chocolate Chip Cookie Bar 12 oz (340g) UPC 36211 68096 9
Bakery & Grains·188 affected·Apr 17, 2017
High RiskFDA
American Pharmaceutical Ingredients Llc
ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8049-4), For Presc...
Drugs·1 affected·Apr 17, 2017
High RiskFDA
Syntho Pharmaceuticals, Inc.
EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharma...
Oral Drugs·5,000 affected·Apr 17, 2017
High RiskFDA
Syntho Pharmaceuticals, Inc.
EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuti...
Oral Drugs·5,000 affected·Apr 17, 2017
High RiskFDA
Conmed Corporation
Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthr...
Surgical Devices·56 affected·Apr 17, 2017
High RiskFDA
Sonarmed Inc
SonarMed AirWave Monitor, Model Number M0001
Medical Devices·16 affected·Apr 17, 2017
High RiskFDA
Zimmer Biomet, Inc.
AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of ...
Medical Devices·33,500 affected·Apr 17, 2017
High RiskFDA
Tp Food Processing Inc.
Lemongrass Satay, Net: 9oz (265gr), 12units/case and 1/2 gallon, 6 units/case
Food·4,140 affected·Apr 15, 2017
High RiskFDA
Tp Food Processing Inc.
Shrimp Satay Hot Dry Shrimp-Chili Sauce, Net: 6 and 9oz , 12 units/case
Seafood·6,612 affected·Apr 15, 2017
High RiskFDA
Whole Foods Market
Decorated (iced) holiday cookies sold in the shape of eggs. These cookies were sold in the self service cookie displays. Individual cook...
Dairy·216 affected·Apr 15, 2017
High RiskFDA
Kemps, Llc
Kemps Sweet Me Creamery Vanilla Bean, One Pint, UPC 41483-04142
Food·91,672 affected·Apr 14, 2017
High RiskFDA
Kemps, Llc
Kemps YO2 Frozen Yogurt Chocolate Peanut Butter Fudge, One Pint, UPC 41483-04126
Dairy·469,568 affected·Apr 14, 2017
High RiskFDA
Kemps, Llc
Kemps YO2 Frozen Yogurt Salty Caramel Cookie Crunch, One Pint, UPC 41483-04123
Dairy·469,568 affected·Apr 14, 2017
High RiskFDA
Kemps, Llc
Kemps Sweet Me Creamery Strawberry Rhubarb Cobbler, One Pint, UPC 41483-04145
Produce·91,672 affected·Apr 14, 2017
High RiskFDA
Kemps, Llc
Kemps Sweet Me Creamery Maple Toffee Blondie, One Pint, UPC 41483-04146
Food·91,672 affected·Apr 14, 2017
High RiskFDA
Kemps, Llc
Kemps YO2 Frozen Yogurt Mudslide, One Pint, UPC 41483-04121
Dairy·469,568 affected·Apr 14, 2017
High RiskFDA
Kemps, Llc
Kemps Sweet Me Creamery Salted Caramel Brownie, One Pint, UPC 41483-04141
Food·91,672 affected·Apr 14, 2017
High RiskFDA
Kemps, Llc
Kemps Sweet Me Creamery Expresso Mocha, One Pint, UPC 41483-04140
Food·91,672 affected·Apr 14, 2017
High RiskFDA
Kemps, Llc
Kemps YO2 Frozen Yogurt Cold Brewed Coffee, One Pint, UPC 41483-04122
Dairy·469,568 affected·Apr 14, 2017
High RiskFDA
Kemps, Llc
Kemps Sweet Me Creamery Chocolate Peanut Butter Pretzel, One Pint, UPC 41483-04144
Dairy·91,672 affected·Apr 14, 2017
High RiskFDA
Kemps, Llc
Kemps YO2 Frozen Yogurt Very Vanilla, One Pint, UPC 41483-04124
Dairy·469,568 affected·Apr 14, 2017
High RiskFDA
Kemps, Llc
Kemps Sweet Me Creamery Creamy Dark Chocolate Mint, One Pint, UPC 41483-04143
Snacks & Candy·91,672 affected·Apr 14, 2017
High RiskFDA
Kemps, Llc
Kemps YO2 Frozen Yogurt Raspberry Cheesecake, One Pint, UPC 41483-04127
Dairy·469,568 affected·Apr 14, 2017
High RiskFDA
Cardiovascular Systems Inc
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
Medical Devices·1,396 affected·Apr 14, 2017
High RiskFDA
General Mills, Inc
Chocolate chip cookie dough larabars, 10 count , UPC 100-21908-49031 incorrectly packaged in peanut butter cookie larabars boxes, 10 coun...
Dairy·33 affected·Apr 13, 2017
High RiskFDA
Spectrum Laboratory Products, Inc.
Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base, Micronized, U.S.P active pharmaceutical ingredient...
Drugs·48 affected·Apr 13, 2017
High RiskFDA
Spectrum Laboratory Products, Inc.
Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg container, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 9...
Drugs·1 affected·Apr 13, 2017
High RiskFDA
Pentax Of America Inc
9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of...
Medical Devices·241 affected·Apr 13, 2017
High RiskFDA
Pentax Of America Inc
9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital vi...
Medical Devices·241 affected·Apr 13, 2017
High RiskFDA
Beckman Coulter Inc.
Access BR Monitor, Part No. 387620
Medical Devices·45,278 affected·Apr 13, 2017
High RiskFDA
Cardiotek Bv
CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, di...
Cardiac Devices·8 affected·Apr 13, 2017
High RiskFDA
Zimmer Biomet, Inc.
Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin
Medical Devices·4,238 affected·Apr 13, 2017