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High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LL...
Oral Drugs·0 affected·May 29, 2020
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceutical...
Oral Drugs·0 affected·May 29, 2020
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal Pharmaceuticals ...
Oral Drugs·192 affected·May 29, 2020
High RiskFDA
Pfizer Inc.
Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distributed by Roerig Divis...
Injectable Drugs·94,320 affected·May 29, 2020
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, Manufactured by: Amneal Pharmaceutical...
Oral Drugs·0 affected·May 29, 2020
High RiskFDA
Glaxosmithkline Consumer Healthcare Holdings
Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135...
Drugs·151,344 affected·May 28, 2020
High RiskFDA
Glaxosmithkline Consumer Healthcare Holdings
Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 0705...
Drugs·629,796 affected·May 28, 2020
High RiskFDA
Quva Pharma, Inc.
oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx only, QuVa Pharma 1075 West Park One Driv...
Injectable Drugs·648 affected·May 28, 2020
High RiskFDA
Lupin Pharmaceuticals Inc.
Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, MD 21202, Manufacture...
Oral Drugs·4,224 affected·May 28, 2020
High RiskFDA
Glaxosmithkline Consumer Healthcare Holdings
Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ (355 mL) single pack and twin pack, Distributed by: GSK Consumer Healthcare W...
Drugs·1,631,700 affected·May 28, 2020
High RiskFDA
Glaxosmithkline Consumer Healthcare Holdings
Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-...
Drugs·119,364 affected·May 28, 2020
High RiskFDA
Carefusion 2200 Inc
Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray
Surgical Devices·0 affected·May 28, 2020
High RiskFDA
Carefusion 2200 Inc
Safe-T-Centesis PLUS 8 Fr Catheter Drainage Tray
Surgical Devices·0 affected·May 28, 2020
High RiskFDA
Carefusion 2200 Inc
Safe-T PLUS Thora-Para 8 Fr Catheter Drainage Tray
Surgical Devices·0 affected·May 28, 2020
High RiskFDA
Carefusion 2200 Inc
Thora-Para 5 Fr Catheter Drainage Tray
Surgical Devices·0 affected·May 28, 2020
High RiskFDA
Carefusion 2200 Inc
Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine
Surgical Devices·0 affected·May 28, 2020
High RiskFDA
Carefusion 2200 Inc
Safe-T-Centesis 8 Fr Catheter Drainage Tray
Surgical Devices·0 affected·May 28, 2020
High RiskFDA
Carefusion 2200 Inc
Safe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage Tray
Surgical Devices·0 affected·May 28, 2020
High RiskFDA
Carefusion 2200 Inc
Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray
Surgical Devices·0 affected·May 28, 2020
High RiskFDA
Carefusion 2200 Inc
Thora-Para 8 Fr Catheter Drainage Tray w/o Lidocaine
Surgical Devices·0 affected·May 28, 2020
High RiskFDA
Carefusion 2200 Inc
Safe-T-Centesis 6 Fr Catheter Drainage Tray
Surgical Devices·0 affected·May 28, 2020
High RiskFDA
Carefusion 2200 Inc
Thora-Para 8 Fr Catheter Drainage Tray
Surgical Devices·0 affected·May 28, 2020
High RiskFDA
Apotex Inc.
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario C...
Oral Drugs·305,963 affected·May 27, 2020
High RiskFDA
Prodimed Plastimed Division
Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x 4.0 mm 58124 40US
Surgical Devices·39,800 affected·May 27, 2020
High RiskFDA
Prodimed Plastimed Division
Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9 mm Product Code: 58 223 ...
Surgical Devices·180 affected·May 27, 2020
High RiskFDA
Prodimed Plastimed Division
Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 60 cm x 2.7 mm Product Code: 58216 27US
Surgical Devices·7,220 affected·May 27, 2020
High RiskFDA
Siemens Healthcare Diagnostics Inc
RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778
Medical Devices·436 affected·May 27, 2020
High RiskFDA
Jubilant Cadista Pharmaceuticals, Inc.
Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 2180...
Oral Drugs·1,313,333 affected·May 26, 2020
High RiskFDA
Radiometer Medical Aps
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available i...
Medical Devices·4,615 affected·May 26, 2020
High RiskFDA
U&i Corp.
ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM
Medical Devices·6 affected·May 26, 2020
High RiskFDA
Radiometer Medical Aps
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011. Model 393-801 is available a...
Medical Devices·3,899 affected·May 26, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1,...
Medical Devices·12 affected·May 26, 2020
High RiskFDA
Smiths Medical Asd Inc.
Pediatric Adjustable Flange Tracheostomy Tube Cuffless
Medical Devices·20 affected·May 26, 2020
High RiskFDA
Teva Pharmaceuticals Usa
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts ...
Oral Drugs·33,280 affected·May 22, 2020
High RiskFDA
Teva Pharmaceuticals Usa
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts ...
Oral Drugs·41,348 affected·May 22, 2020
High RiskFDA
Teva Pharmaceuticals Usa
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts ...
Oral Drugs·84,209 affected·May 22, 2020
High RiskFDA
The Harvard Drug Group
Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x 10 unit dose carton (NDC 09...
Oral Drugs·16,443 affected·May 22, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F
Cardiac Devices·0 affected·May 22, 2020
High RiskFDA
Tosoh Bioscience Inc
AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
Medical Devices·529 affected·May 22, 2020
High RiskFDA
Abbott
TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) -...
Cardiac Devices·84,104 affected·May 22, 2020
High RiskFDA
Captain Rusty's Seafood Products Llc
Captain Rusty's Smoked Salmon Dip, A Taste of the Pacific Coast, Keep Refrigerated, 16 oz.
Seafood·0 affected·May 21, 2020
High RiskFDA
Vitalconnect Inc.
VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professionals to display phys...
Medical Devices·7 affected·May 21, 2020
High RiskFDA
La Sonorense, Inc.
La Sonorense Tortilla Factory, Flour Burrito Size, One Dozen, NET WT. 1 lb. 6 oz. (22 oz.)
Food·40 affected·May 20, 2020
High RiskFDA
La Sonorense, Inc.
La Sonorense Tortilla Factory, Gorditas Sonora Style, One Dozen, NET WT. 1 lb. 6 oz. (22 oz.)
Food·247 affected·May 20, 2020
High RiskFDA
Ortho Clinical Diagnostics
VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979
Diagnostic Devices·779 affected·May 20, 2020
High RiskFDA
Ortho Clinical Diagnostics
VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
Medical Devices·130 affected·May 20, 2020
High RiskFDA
Ortho Clinical Diagnostics
VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610
Medical Devices·353 affected·May 20, 2020
High RiskFDA
Wuhan Bingbing Pharmaceutical Co., Ltd.
LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches per box, Manufactured For: Terrain Pharmaceuticals, Reno, NV 8...
Topical Drugs·54,000 affected·May 19, 2020