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High RiskFDA
Kroger Specialty Pharmacy, Inc.
Revlimid 5 mg oral cap NDC 59572-0405-28 28 days supply
Oral Drugs·0 affected·Apr 3, 2018
High RiskFDA
Kroger Specialty Pharmacy, Inc.
Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply
Oral Drugs·0 affected·Apr 3, 2018
High RiskFDA
Kroger Specialty Pharmacy, Inc.
Letrozole 2.5 mg tab NDC 51991-0759-33 30 days supply
Drugs·0 affected·Apr 3, 2018
High RiskFDA
Kroger Specialty Pharmacy, Inc.
Xalkori 250 mg cap NDC 00069-8140-20 30 days supply
Drugs·0 affected·Apr 3, 2018
High RiskFDA
Kroger Specialty Pharmacy, Inc.
Tecfidera 240 mg capsule NDC 64406-0006-02 30 days supply
Oral Drugs·0 affected·Apr 3, 2018
High RiskFDA
Kroger Specialty Pharmacy, Inc.
Temozolomide 20 mg NDC 43975-0253-05 28 days supply
Drugs·0 affected·Apr 3, 2018
High RiskFDA
Kroger Specialty Pharmacy, Inc.
Pediasure Liq. Vanilla G+G (CAN) #24 24 days supply, NDC 70074-0558-98
Drugs·0 affected·Apr 3, 2018
High RiskFDA
Roche Diagnostics Corporation
cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for i...
Diagnostic Devices·35 affected·Apr 3, 2018
High RiskFDA
Baxter Healthcare Corporation
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR Product Usage: The Baxter Sigma Spectrum Infusion ...
Medical Devices·444 affected·Apr 3, 2018
High RiskFDA
Baxter Healthcare Corporation
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE Product Usage: The Baxter Sigma Spectrum Infusion...
Medical Devices·444 affected·Apr 3, 2018
High RiskFDA
Baxter Healthcare Corporation
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion P...
Medical Devices·444 affected·Apr 3, 2018
High RiskFDA
Baxter Healthcare Corporation
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion ...
Medical Devices·444 affected·Apr 3, 2018
High RiskFDA
Diamond Wipes International, Inc.
WipeEssentials Wet Wipes (benzalkonium chloride 0.13%), 30-count pouches, Dist. by Diamond Wipes Int'l, Inc., Chino, CA 91710, UPC 7 666...
Drugs·5,148,792 affected·Apr 2, 2018
High RiskFDA
Diamond Wipes International, Inc.
ACURE, clarifying acne, glycolic + zinc (salicyclic acid 0.5%) towelettes, 30-count pouch, Distributed by Better Planet Brands, Fort Laud...
Drugs·51,840 affected·Apr 2, 2018
High RiskFDA
Synthes (usa) Products Llc
Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
Medical Devices·235 affected·Apr 2, 2018
High RiskFDA
Smiths Medical Asd Inc.
Bivona¿ Tracheostomy Tube Tracheostomy Tubes
Medical Devices·16 affected·Apr 2, 2018
High RiskFDA
Synthes (usa) Products Llc
Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630
Medical Devices·196 affected·Apr 2, 2018
High RiskFDA
Zimmer Biomet, Inc.
Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/polymer semi-constrained cemented prosthesis The device ...
Medical Implants·30 affected·Apr 2, 2018
High RiskFDA
Aesdex
AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number: FG-000150 The Cardica C-Port Flex-A PLUS Distal An...
Medical Devices·400 affected·Apr 2, 2018
High RiskFDA
Advocare International, Lp
AdvoCare Muscle Strength Dietary Supplement with HMB and Suma Product code, P3221
Supplements·15,640 affected·Mar 30, 2018
High RiskFDA
Advocare International, Lp
AdvoCare Nighttime Recovery Amino Acid and Herbal Dietary Supplement Product code, P3201
Supplements·48,176 affected·Mar 30, 2018
High RiskFDA
Avkare Inc.
Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 502...
Oral Drugs·2,135 affected·Mar 30, 2018
High RiskFDA
Marcas Usa Llc
PASTA DE LASSAR ANDROMACO Skin Protection, 25% zinc oxide Topical cream, 60 gram tube, UPC #851357003004, NDC #75940-111-60
Topical Drugs·69,238 affected·Mar 30, 2018
High RiskFDA
Think Surgical, Inc.
Think Surgical Cutter, Flat, ¿6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Part Number 106428 The cutter is us...
Surgical Devices·951 affected·Mar 30, 2018
High RiskFDA
Smith & Nephew, Inc.
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients in primary and rev...
Medical Devices·0 affected·Mar 30, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray system
Medical Devices·2 affected·Mar 30, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system
Medical Devices·20 affected·Mar 30, 2018
High RiskFDA
Immuno-mycologics, Inc
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatograp...
Diagnostic Devices·875 affected·Mar 30, 2018
High RiskFDA
Smith & Nephew, Inc.
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and re...
Medical Devices·16 affected·Mar 30, 2018
High RiskFDA
Ge Medical Systems, Llc
MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE Signa¿ 3.0T or 1.5T magnetic resonance scanner (pr...
Cardiac Devices·54 affected·Mar 30, 2018
High RiskFDA
Pentax Of America Inc
C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surger...
Surgical Devices·57 affected·Mar 30, 2018
High RiskFDA
Purely Elizabeth.
Chocolate Sea Salt Probiotic Granola, Purely Elizabeth, 8oz, PET/LLDPE Pouch, 6 units/case,
Bakery & Grains·61 affected·Mar 29, 2018
High RiskFDA
United Pacific Co Ltd
Zhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC 6 924938 100226, NDC 53614-001-02
Topical Drugs·15,190 affected·Mar 29, 2018
High RiskFDA
Ge Medical Systems, Scs
Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
Medical Devices·102 affected·Mar 29, 2018
High RiskFDA
Ge Medical Systems, Scs
Discovery IGS 730 Interventional Fluoroscopic X-ray Systems
Medical Devices·102 affected·Mar 29, 2018
High RiskFDA
Cook Inc.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS Product Usage: The connecting tube is intended to be a conduit betwee...
Surgical Devices·220 affected·Mar 29, 2018
High RiskFDA
Cook Inc.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM Product Usage: The connecting tube is intended to be a conduit between a...
Surgical Devices·554 affected·Mar 29, 2018
High RiskFDA
Cook Inc.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended to be a conduit between a ...
Surgical Devices·6,345 affected·Mar 29, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving c...
Medical Devices·1,145 affected·Mar 29, 2018
High RiskFDA
Cook Inc.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage: The connecting tube is intended to be a conduit between a ...
Surgical Devices·304 affected·Mar 29, 2018
High RiskFDA
Stryker Sustainability Solutions
Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304. Product Usage: T...
Cardiac Devices·2,722 affected·Mar 29, 2018
High RiskFDA
Ge Medical Systems, Scs
Discovery IGS 740 Interventional Fluoroscopic X-ray Systems
Medical Devices·102 affected·Mar 29, 2018
High RiskFDA
Elroselabs Inc.
Conzerol zero molluscum contagiosum, Topical Cream, Net weight 0.78 (22g), Elrose Labs, Sanford Fl 32771 USA --- NDC 70223-001-06
Topical Drugs·0 affected·Mar 28, 2018
High RiskFDA
Elroselabs Inc.
Molleave, 2 oz bottle, OTC, Manufactured for Elrose Labs, Inc.
Drugs·0 affected·Mar 28, 2018
High RiskFDA
Elroselabs Inc.
Conzerol (antipoxin) H2O2 Gel, Hydrogen Peroxide Gel 3%, 1.5 oz. tube, OTC, Manufactured for Elrose Labs, Inc., Sanford, FL
Topical Drugs·0 affected·Mar 28, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance Big Bore Radiology 728244
Medical Devices·28 affected·Mar 28, 2018
High RiskFDA
Draegar Medical Systems, Inc.
Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS2...
Medical Devices·25 affected·Mar 28, 2018
High RiskFDA
Cardinal Health 200, Llc
Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561-920C To rem...
Surgical Devices·3,600 affected·Mar 28, 2018