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High RiskFDA
Direct Rx
Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90 Packa...
Oral Drugs·30 affected·Mar 13, 2023
High RiskFDA
Direct Rx
Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx, Dawsonv...
Oral Drugs·51 affected·Mar 13, 2023
High RiskFDA
Direct Rx
Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct Rx, Dawsonville, ...
Drugs·269 affected·Mar 13, 2023
High RiskFDA
Direct Rx
Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Daws...
Oral Drugs·9 affected·Mar 13, 2023
High RiskFDA
Direct Rx
Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61919-0250-90 Packa...
Oral Drugs·30 affected·Mar 13, 2023
High RiskFDA
Direct Rx
Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61919-0448-90 Packa...
Oral Drugs·30 affected·Mar 13, 2023
High RiskFDA
Direct Rx
Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonv...
Oral Drugs·4 affected·Mar 13, 2023
High RiskFDA
Direct Rx
Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packa...
Oral Drugs·30 affected·Mar 13, 2023
High RiskFDA
Direct Rx
Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx
Oral Drugs·19 affected·Mar 13, 2023
High RiskFDA
Direct Rx
Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 6191...
Oral Drugs·90 affected·Mar 13, 2023
High RiskFDA
Direct Rx
Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61919-0446-90, Pack...
Oral Drugs·30 affected·Mar 13, 2023
High RiskFDA
Noven Pharmaceuticals Inc
Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by N...
Drugs·0 affected·Mar 10, 2023
High RiskFDA
Noven Pharmaceuticals Inc
Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by No...
Drugs·0 affected·Mar 10, 2023
High RiskFDA
Noven Pharmaceuticals Inc
Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by N...
Drugs·0 affected·Mar 10, 2023
High RiskFDA
Noven Pharmaceuticals Inc
Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by No...
Drugs·0 affected·Mar 10, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analy...
Diagnostic Devices·4,895 affected·Mar 10, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of a...
Diagnostic Devices·2,001 affected·Mar 10, 2023
High RiskFDA
Howmedica Osteonics Corp.
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
Surgical Devices·102 affected·Mar 10, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a ...
Diagnostic Devices·1,148 affected·Mar 10, 2023
High RiskFDA
Alcon Research, Llc
Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-...
Surgical Devices·1,035 affected·Mar 10, 2023
High RiskFDA
20-100 Delicious Seasoning Llc
Sofrito Marinating Sauce, 100% All Natural Ingredients (Caribbean Seasoning), Net Wt 16 oz. (460g), 8 oz. (230g) and 32(920g) oz. Glass J...
Food·8 affected·Mar 9, 2023
High RiskFDA
Boehringer Ingelheim Pharmaceuticals, Inc.
JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-count (NDC 0597-0153-90) bottles, Rx only, ...
Oral Drugs·69,375 affected·Mar 9, 2023
High RiskFDA
Philips North America Llc
Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201
Diagnostic Devices·10 affected·Mar 9, 2023
High RiskFDA
Philips North America Llc
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
Diagnostic Devices·10 affected·Mar 9, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Ve...
Diagnostic Devices·256 affected·Mar 9, 2023
High RiskFDA
Devilbiss Healthcare Llc
DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
Respiratory Devices·143,397 affected·Mar 9, 2023
High RiskFDA
Medacta Usa Inc
MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device
Medical Devices·32 affected·Mar 8, 2023
High RiskFDA
Radiometer Medical Aps
AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devic...
Medical Devices·1,806 affected·Mar 8, 2023
High RiskFDA
Medacta Usa Inc
MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device
Medical Devices·44 affected·Mar 8, 2023
High RiskFDA
Biofire Diagnostics, Llc
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
Medical Devices·900 affected·Mar 8, 2023
High RiskFDA
Medacta Usa Inc
MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device
Medical Devices·50 affected·Mar 8, 2023
High RiskFDA
Natural Solutions Foundation
Dr. Rima Recommends The Silver Solution Immune System Support Dietary Supplement Nano Silver 10 ppm 16 fl. oz. (473 ml)
Supplements·0 affected·Mar 7, 2023
High RiskFDA
Compass Health Brands (corporate Office)
REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, ...
Medical Devices·30 affected·Mar 7, 2023
High RiskFDA
Maquet Cardiovascular, Llc
VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
Medical Devices·2,300 affected·Mar 6, 2023
High RiskFDA
Maquet Cardiovascular, Llc
VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W
Medical Devices·235 affected·Mar 6, 2023
High RiskFDA
Philips North America Llc
EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
Medical Devices·64 affected·Mar 6, 2023
High RiskFDA
Philips North America Llc
EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380
Medical Devices·1,421 affected·Mar 6, 2023
High RiskFDA
Daiso California Warehouse
Kajitani food cigar fry 110g UPC: 4901332108289
Food·1,366 affected·Mar 3, 2023
High RiskFDA
Daiso California Warehouse
Takuma food dashi salt peanut 80g UPC: 4962679652750
Food·1,064 affected·Mar 3, 2023
High RiskFDA
Daiso California Warehouse
Ajikal 44g Kotsubukko 4 series UPC: 4510656600708
Food·51,626 affected·Mar 3, 2023
High RiskFDA
Daiso California Warehouse
Okabe Funagata small grilled small sardine 43g UPC: 4971455077236
Food·4,904 affected·Mar 3, 2023
High RiskFDA
Daiso California Warehouse
Wadakan sukiyaki sauce 300ml UPC: 4903636311594
Food·73 affected·Mar 3, 2023
High RiskFDA
Daiso California Warehouse
Mangetsu Ebisen 54g UPC: 4901053011370
Food·2,395 affected·Mar 3, 2023
High RiskFDA
Daiso California Warehouse
Ajikal Age Ichiban 97g UPC: 4510656600906
Food·204,680 affected·Mar 3, 2023
High RiskFDA
Daiso California Warehouse
Daisho crab miso soup 750g UPC: 4904621043919
Seafood·2,987 affected·Mar 3, 2023
High RiskFDA
Daiso California Warehouse
Kanro Non-Sugar Tea House 40g UPC: 4901351013144
Beverages·8,742 affected·Mar 3, 2023
High RiskFDA
Daiso California Warehouse
Saint Lavian mini pound cake chocolate 2 pieces UPC: 4973341408841
Bakery & Grains·2,298 affected·Mar 3, 2023
High RiskFDA
Daiso California Warehouse
Kurata Foods Vegetable Potage V Ramen 2 servings UPC: 4906436005304
Produce·3,891 affected·Mar 3, 2023