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High RiskFDA
Wells Pharmacy Network Llc
Alprostadil 40 mcg/mL Injectable, 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL
Injectable Drugs·37 affected·Sep 21, 2016
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody recognizes an epitope on the extracellular domain of a 3640 ...
Medical Devices·14 affected·Sep 21, 2016
High RiskFDA
Leiter's Compounding
Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Vo...
Injectable Drugs·76,315 affected·Sep 20, 2016
High RiskFDA
Leiter's Compounding
Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA
Drugs·76,315 affected·Sep 20, 2016
High RiskFDA
Leiter's Compounding
Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter'...
Ophthalmic Drugs·76,315 affected·Sep 20, 2016
High RiskFDA
Leiter's Compounding
Brilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's ...
Injectable Drugs·76,315 affected·Sep 20, 2016
High RiskFDA
Leiter's Compounding
Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL Total Volume in a 2 mL Vial, Compounded by Lei...
Injectable Drugs·76,315 affected·Sep 20, 2016
High RiskFDA
Leiter's Compounding
Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leite...
Injectable Drugs·76,315 affected·Sep 20, 2016
High RiskFDA
Leiter's Compounding
Vancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Com...
Injectable Drugs·76,315 affected·Sep 20, 2016
High RiskFDA
Leiter's Compounding
Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free...
Injectable Drugs·76,315 affected·Sep 20, 2016
High RiskFDA
Leiter's Compounding
Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded ...
Injectable Drugs·76,315 affected·Sep 20, 2016
High RiskFDA
Custom Medical Specialties, Inc.
CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties,...
Medical Devices·80 affected·Sep 20, 2016
High RiskFDA
Kellogg Company
Kelloggs ¿ Eggo ¿ Nutri-Grain¿ Whole Wheat Waffles 12.3 oz (10 ct) retail carton 8, 12.3 oz retail cartons per case
Food·10,950 affected·Sep 19, 2016
High RiskFDA
Wells Pharmacy Network, Llc
Testosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Network
Drugs·690 affected·Sep 19, 2016
High RiskFDA
Wells Pharmacy Network, Llc
Testosterone 200 mg/Anastrazole 20mg Pellet, Compounded by: Wells Pharmacy Network
Drugs·318 affected·Sep 19, 2016
High RiskFDA
Wells Pharmacy Network, Llc
Testosterone 60 mg/Anastrazole 4 mg Pellet, Compounded by: Wells Pharmacy Network
Drugs·358 affected·Sep 19, 2016
High RiskFDA
New Star Lasers, Inc.
ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tis...
Medical Devices·5 affected·Sep 19, 2016
High RiskFDA
Encore Medical, Lp
Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior sta...
Medical Implants·162 affected·Sep 19, 2016
High RiskFDA
New Star Lasers, Inc.
CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision, excision, ablatio...
Medical Devices·44 affected·Sep 19, 2016
High RiskFDA
Tornier, Inc
Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DW...
Medical Implants·30 affected·Sep 19, 2016
High RiskFDA
Philips Electronics North America Corporation
Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Product Number: 865351 Worldwide Except USA Exchang...
Medical Devices·1,824 affected·Sep 19, 2016
High RiskFDA
Stryker Sustainability Solutions
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet sys...
Surgical Devices·1,695,760 affected·Sep 19, 2016
High RiskFDA
Koffee Kup Bakery Inc.
Big Y Plain Grinders- Enriched wheat and Enriched White packaged 15 oz
Food·98,893 affected·Sep 17, 2016
High RiskFDA
Koffee Kup Bakery Inc.
Koffee Kup Kaiser Rolls: Egg, Plain, Corn, White, Wheat, Sesame, Seeded Poppy packaged 12, and 15 oz
Food·98,893 affected·Sep 17, 2016
High RiskFDA
Koffee Kup Bakery Inc.
Big Y Plain Bulkie Rolls-white packaged 15 oz and 17 oz
Food·98,893 affected·Sep 17, 2016
High RiskFDA
Koffee Kup Bakery Inc.
Koffee Kup Potatoe Hamburger Buns, Plain and Seeded, 8 pk
Food·98,893 affected·Sep 17, 2016
High RiskFDA
Koffee Kup Bakery Inc.
Koffee Kup Hoogie Rolls- Wheat, Sourdough, Potatoe packaged 15 oz and 15.6 and 17 oz
Food·98,893 affected·Sep 17, 2016
High RiskFDA
Koffee Kup Bakery Inc.
Koffee Kup Bar-B-Que Sweet Buns- Plain, Corn, Sesame Seed and Wheat w/Oat Topping, packaged 8 oz.
Food·98,893 affected·Sep 17, 2016
High RiskFDA
Koffee Kup Bakery Inc.
Koffee Kup Grinder Rolls-white 9' and Italian 9", packaged 20.4 oz.
Food·98,893 affected·Sep 17, 2016
High RiskFDA
Koffee Kup Bakery Inc.
Market Basket Bulkie Rolls- Plain, Wheat packaged 15.6 oz
Food·98,893 affected·Sep 17, 2016
High RiskFDA
Koffee Kup Bakery Inc.
Market Basket Plain Sub (Grinder) rolls-
Food·98,893 affected·Sep 17, 2016
High RiskFDA
Koffee Kup Bakery Inc.
Koffee Kup Sandwich Rolls- Plain, packaged 17 oz and 27 oz
Food·98,893 affected·Sep 17, 2016
High RiskFDA
Koffee Kup Bakery Inc.
Koffee Kup Hamburger Buns- White, Wheat, Seeded -3 1/2" 4", 5", packaged 16 oz. 18, oz, 20 oz, 25 oz, 29 oz
Food·98,893 affected·Sep 17, 2016
High RiskFDA
Koffee Kup Bakery Inc.
Koffee Kup Hot Dog Buns- 8 pk and 16 pk
Food·98,893 affected·Sep 17, 2016
High RiskFDA
Hospira Inc., A Pfizer Company
Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest,...
Injectable Drugs·15 affected·Sep 16, 2016
High RiskFDA
Hospira Inc., A Pfizer Company
Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL...
Injectable Drugs·4,768 affected·Sep 16, 2016
High RiskFDA
Natus Medical Incorporated
Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and can be used in a bassinet, op...
Medical Devices·713 affected·Sep 16, 2016
High RiskFDA
Randox Laboratories
The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocy...
Cardiac Devices·2,817 affected·Sep 16, 2016
High RiskFDA
Becton Dickinson & Company
BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypodermic Syringe is intended for use by health care professional...
Medical Devices·547,600 affected·Sep 16, 2016
High RiskFDA
Ion Beam Applications S.a.
Proteus ONE and Proteus Plus
Medical Devices·0 affected·Sep 16, 2016
High RiskFDA
Ge Healthcare, Llc
Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
Diagnostic Devices·58 affected·Sep 16, 2016
High RiskFDA
Becton Dickinson & Company
BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062
Medical Devices·22,400 affected·Sep 16, 2016
High RiskFDA
Becton Dickinson & Company
BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for ...
Medical Devices·648,000 affected·Sep 16, 2016
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information manageme...
Medical Devices·251 affected·Sep 15, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calc...
Diabetes Devices·9,935 affected·Sep 15, 2016
High RiskFDA
Keystone Dental Inc
Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are intended for us...
Medical Implants·55 affected·Sep 15, 2016
High RiskFDA
Biomet 3i, Llc
BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component dir...
Medical Implants·216 affected·Sep 14, 2016
High RiskFDA
Biomet 3i, Llc
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic compone...
Medical Implants·191 affected·Sep 14, 2016