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High RiskFDA
Walgreens Infusion Services
Meropenem 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drugs·35 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
0.9% Sodium Chloride injection bag, a) 500 mL, b)1000 mL c)2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Injectable Drugs·43 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
3-in-1 TPN formula daily+overfill Bag, 2000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drugs·87 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Clindamycin injection, Accuflo bag, a) 500 mg/NS 50 mL b) 900 mg/NS 100 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 7823...
Injectable Drugs·30 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Remicade (Infliximab) injection, 5 mg/kg bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Injectable Drugs·1 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Sodium Ascorbate (Vitamin C) syringe, a) 500 mg/1 mL syringe, b)1000 mg/2 mL c) 800 mg/1.6 mL, Rx Only, Compounded by Option Care 148, Sa...
Supplements·30 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Milrinone 0.375 mcg/kg/min D5W bag a) 365 mL, b) 400 mL c) 430 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drugs·19 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Insulin Regular (Human) syringe, a)15 unit/0.15 mL, b) 24 unit/0.24mL syringe, c) 50 unit/0.5 mL, Rx Only, Compounded by Option Care 148,...
Drugs·23 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Thiamine 100 mg (1 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drugs·23 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Teflaro 600 mg in 100 mL NS Minibag Plus,Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drugs·63 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Cefepime 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drugs·26 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Cefazolin in Accuflo bags, a) 1g/NS 25 mL, b) 2g/NS 25 mL, c) 8g/NS 275 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232...
Drugs·34 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Pedi MVI a) 5 mL, b) 10 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drugs·73 affected·Nov 10, 2015
High RiskFDA
Shimadzu Medical Systems
Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general...
Medical Devices·297 affected·Nov 10, 2015
High RiskFDA
Philips Healthcare
Philips Healthcare DigitalDiagnost stationary X-ray system
Diagnostic Devices·160 affected·Nov 10, 2015
High RiskFDA
C.r. Bard, Inc.
Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
Medical Devices·1,539 affected·Nov 10, 2015
High RiskFDA
Aesculap, Inc.
Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aesculap AG These instruments are intended for use during the ...
Medical Implants·37 affected·Nov 10, 2015
High RiskFDA
Zimmer, Inc.
Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger Handpiece. Rx only Made in Switzerland
Medical Devices·89 affected·Nov 10, 2015
High RiskFDA
Philips Healthcare
Philips Healthcare DuraDiagnost stationary X-ray system
Diagnostic Devices·5 affected·Nov 10, 2015
High RiskFDA
Aesculap, Inc.
Flexible Drill; SJ723R; NON STERILE; B Braun Aesculap; Aesculap AG These instruments are intended for use during the implantati...
Medical Implants·13 affected·Nov 10, 2015
High RiskFDA
Siemens Healthcare Diagnostics Inc.
Reagent Management System (RMS) Dimension EXL with LM STM Product Usage: The Reagent Management System (RMS) is a module for use wi...
Diagnostic Devices·4 affected·Nov 10, 2015
High RiskFDA
Orthopediatrics Corp
UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabili...
Medical Devices·102 affected·Nov 10, 2015
High RiskFDA
Nutritional Resources Inc
Healthwise, Protein Chips, Barbecue Crunch, Net Weight 1.2 ounces (34 grams), Distributed by Nutritional Resources, Inc., Grovetown, GA ...
Snacks & Candy·94,080 affected·Nov 9, 2015
High RiskFDA
Freedom Pharmaceuticals Inc
Baclofen USP powder, packaged in (a) 25gm (4 oz container), (b) 100gm (16 oz container), (c) 500 gm (70 oz container), and (d) 1000 gm ...
Drugs·6 affected·Nov 9, 2015
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, ST...
Medical Implants·20 affected·Nov 9, 2015
High RiskFDA
Medtronic Inc.
Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.
Medical Implants·96,787 affected·Nov 9, 2015
High RiskFDA
Vidco, Inc.
Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4. The MDP2000 is intended for use ...
Cardiac Devices·59 affected·Nov 8, 2015
High RiskFDA
Yummy Earth Inc
YumEarth Organics Gummy Worms Net Wt. 5 oz. Distributed by YummyEarth Inc., Ramsey, NJ 07446 UPC 810165018259
Food·66,312 affected·Nov 6, 2015
High RiskFDA
Yummy Earth Inc
YumEarth Organics Gummy Bears 5 oz. Distributed by YummyEarth Inc., Ramsey, NJ 07446 UPC 810165018310
Food·74,088 affected·Nov 6, 2015
High RiskFDA
Yummy Earth Inc
YumEarth Organics Gummy Bears and Gummy Worms Net Wt. 15 oz. Distributed by Yummy Earth, Ramsey, NY 07446 UPC 810165018273
Food·7,308 affected·Nov 6, 2015
High RiskFDA
Saputo Dairy Foods Usa, Llc
1.) Essential EVERYDAY Chocolate Flavored Dairy Whipped Topping, Made with Real Cream, Ultra-Pasteurized Grade A, NET WT 13 OZ (368g); 2....
Dairy·11 affected·Nov 6, 2015
High RiskFDA
Myco Medical Supplies Inc
Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle
Medical Devices·2,401,419 affected·Nov 6, 2015
High RiskFDA
Remel Inc
Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. ...
Medical Devices·58 affected·Nov 6, 2015
High RiskFDA
Terumo Medical Corporation
Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.
Diagnostic Devices·5,252 affected·Nov 6, 2015
High RiskFDA
Cardica, Inc.
MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip C...
Surgical Devices·568 affected·Nov 6, 2015
High RiskFDA
The Kroger Co
Kroger 100% natural apple FROM CONCENTRATE 64FL OZ. INGREDIENTS: APPLE JUICE FROM CONCENTRATE (FILTERED WATER, APPLE JUICE CONCENTRATE, A...
Beverages·95,176 affected·Nov 5, 2015
High RiskFDA
Brainlab Ag
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation...
Medical Devices·48 affected·Nov 5, 2015
High RiskFDA
Carefusion 303, Inc.
Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserte...
Surgical Devices·1,445,180 affected·Nov 5, 2015
High RiskFDA
Brainlab Ag
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation...
Medical Devices·20 affected·Nov 5, 2015
High RiskFDA
Genesys Orthopedics Systems, Llc
Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterio...
Medical Devices·120 affected·Nov 5, 2015
High RiskFDA
Contes Pasta Company, Inc.
Conte's Gluten Free Wheat Free Cheese Ravioli With Marinara Sauce (French Labeling - Raviolis Au Fromage avec sauce Marinara) Net Wt. 34...
Dairy·54 affected·Nov 4, 2015
High RiskFDA
Contes Pasta Company, Inc.
Conte's Gluten Free Wheat Free Cheese Ravioli Net Wt. 12 Ounces Conte's Pasta Co. Inc. 310 Wheat Road, Vineland, NJ 08360 800.211.6607 w...
Dairy·1,020 affected·Nov 4, 2015
High RiskFDA
Contes Pasta Company, Inc.
Metro Brand Irresistibles Gluten Free Cheese Ravioli with Marinara Sauce Microwave Meal 340 g Use By 020317; Imported for Metro Brands, M...
Dairy·340 affected·Nov 4, 2015
High RiskFDA
Contes Pasta Company, Inc.
Conte's Gluten Free Wheat Free Cheese Ravioli With Marinara Sauce Net Wt. 12 Ounces Conte's Pasta Co. Inc. 310 Wheat Road, Vineland, NJ ...
Dairy·41 affected·Nov 4, 2015
High RiskFDA
Pine Pharmaceuticals, Llc
Bevacizumab 1.25 mg/0.05 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, T...
Drugs·0 affected·Nov 4, 2015
High RiskFDA
Pine Pharmaceuticals, Llc
Bevacizumab 2 mg/0.08 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Ton...
Drugs·0 affected·Nov 4, 2015
High RiskFDA
Pine Pharmaceuticals, Llc
Bevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal injection, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Sui...
Injectable Drugs·0 affected·Nov 4, 2015
High RiskFDA
Pine Pharmaceuticals, Llc
Bevacizumab 1.25 mg/0.05 mL filled to 0.06 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woo...
Drugs·0 affected·Nov 4, 2015