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Akorn, Inc.
CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 0289...
Topical Drugs·0 affected·Feb 21, 2020
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Akorn, Inc.
Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35
Topical Drugs·720 affected·Feb 21, 2020
High RiskFDA
Epimed International
R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(01)10818788021493 - Product Usage: The E...
Medical Devices·1,374 affected·Feb 21, 2020
High RiskFDA
Epimed International
R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124; REF/UDI: 257-2010D(01)00818788022127 - Product Usage:The Ep...
Medical Devices·701 affected·Feb 21, 2020
High RiskFDA
Grain Processing Corporation
Pure Dent¿ B700 Food Corn Starch packaged in 50 lb bags
Food·3,790 affected·Feb 20, 2020
High RiskFDA
Teva Pharmaceuticals Usa
Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauder...
Oral Drugs·3,695 affected·Feb 20, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system
Medical Devices·1 affected·Feb 20, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatment planning system
Medical Devices·1 affected·Feb 20, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software treatment planning system
Medical Devices·1 affected·Feb 20, 2020
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
Medical Devices·255 affected·Feb 20, 2020
High RiskFDA
Philips North America, Llc
Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.0...
Medical Devices·2,214 affected·Feb 20, 2020
High RiskFDA
Radiometer Medical Aps
TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), T...
Medical Devices·84 affected·Feb 20, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system
Medical Devices·1 affected·Feb 20, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system
Medical Devices·1 affected·Feb 20, 2020
High RiskFDA
Vitamin Cottage Natural Food Markets, Inc.
NATURAL GROCERS ALMOND CLUSTERS DK CHOCOLATE NON-GMO, 8 oz. (227g), packed in a plastic bag, UPC 000087236088, Packaged by Vitamin Cottag...
Snacks & Candy·17,041 affected·Feb 19, 2020
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Pro-form Manufacturing Llc
Nature's Sunshine NutriSmart Polvo Para Preparar Bebida Sabor Vainilla Con In Toque Sabor a Chocolate; Vainilla Flavor Contenido Neto ...
Snacks & Candy·4,071 affected·Feb 19, 2020
High RiskFDA
Vitamin Cottage Natural Food Markets, Inc.
NATURAL GROCERS PEANUT CLUSTERS DK CHOCOLATE NON-GMO, 8 oz. (227g), packed in a plastic bag, UPC 000087562088, Packaged by Vitamin Cottag...
Snacks & Candy·22,381 affected·Feb 19, 2020
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Pro-form Manufacturing Llc
Lifetime Fitness D. Tox Shake Mix; Plant-Based Protein Blend. Dietary Supplement - Net Wt. 2.36 lb. (37.76 oz.) 1.07 kg Program Kit - ...
Supplements·3,246 affected·Feb 19, 2020
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Pro-form Manufacturing Llc
Nature's Sunshine NutriSmart Mezcla en polvo a base de proteina de soya enriquecida con vitaminas y minerals; Vainilla Plastic HDPE jar...
Supplements·4,091 affected·Feb 19, 2020
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Pro-form Manufacturing Llc
Lifetime Fitness D. Tox Shake Mix; Plant-Based Protein Blend. Dietary Supplement - Net Wt. 2.50 lb. (40 oz.) 1.13 kg One gallon White ...
Snacks & Candy·5,093 affected·Feb 19, 2020
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Pro-form Manufacturing Llc
Nature's Sunshine SmartMeal Nutritional Shake Mix; Natural Chocolate Flavor Net Wt. 1 lb. 3.5 oz. (555 Grams) UPC: 0 99904 03084 8 Pr...
Snacks & Candy·7,271 affected·Feb 19, 2020
High RiskFDA
Lupin Pharmaceuticals Inc.
Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD
Topical Drugs·876 affected·Feb 19, 2020
High RiskFDA
Haemonetics Corporation
TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagul...
Medical Devices·88 affected·Feb 19, 2020
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Paleonola Llc
Paleonola Grain Free Granola; Pumpkin Pie; packaged in 10oz stand-up pouches; UPC 013964497137
Bakery & Grains·7,388 affected·Feb 18, 2020
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Paleonola Llc
Paleonola Grain Free Granola; Maple Pancake; packaged in 10oz stand-up pouches; UPC 013964497120
Bakery & Grains·7,388 affected·Feb 18, 2020
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Paleonola Llc
Paleonola Grain Free Granola; Chocolate Fix; packaged in 10oz stand-up pouches; UPC 013964497113
Bakery & Grains·7,388 affected·Feb 18, 2020
CriticalFDA
Saratoga Potato Chips Llc
Kroger Sweet & Mesquite BBQ potato chips -17 oz. UPC: 0-11110-03201-0
Snacks & Candy·1,120 affected·Feb 18, 2020
RecallFDA
Paleonola Llc
Paleonola Grain Free Granola; The Original; packaged in 10oz stand-up pouches; UPC 013964497144
Bakery & Grains·7,388 affected·Feb 18, 2020
RecallFDA
Paleonola Llc
Paleonola Grain Free Granola; Pina Colada; packaged in 10oz stand-up pouches; UPC 091037367808
Bakery & Grains·7,388 affected·Feb 18, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 ...
Medical Devices·1,012 affected·Feb 18, 2020
High RiskFDA
Avid Medical, Inc.
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surge...
Medical Devices·1,644 affected·Feb 18, 2020
High RiskFDA
Microbiologics Inc
QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control m...
Diagnostic Devices·10 affected·Feb 18, 2020
High RiskFDA
Avid Medical, Inc.
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surge...
Medical Devices·628 affected·Feb 18, 2020
High RiskFDA
Avid Medical, Inc.
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surge...
Medical Devices·5,004 affected·Feb 18, 2020
High RiskFDA
Avid Medical, Inc.
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surge...
Medical Devices·400 affected·Feb 18, 2020
High RiskFDA
Randox Laboratories Ltd.
Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, i...
Diagnostic Devices·186 affected·Feb 18, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Syst...
Medical Devices·1,012 affected·Feb 18, 2020
High RiskFDA
Avid Medical, Inc.
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surge...
Medical Devices·21,326 affected·Feb 18, 2020
High RiskFDA
Avid Medical, Inc.
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surge...
Medical Devices·2,632 affected·Feb 18, 2020
High RiskFDA
Microbiologics Inc
QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture). KWIK-STIK kit that contains Catalog...
Diagnostic Devices·3 affected·Feb 18, 2020
High RiskFDA
Microbiologics Inc
LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms
Diagnostic Devices·183 affected·Feb 18, 2020
RecallFDA
Strides Pharma Science Limited
Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count bottle, Rx only, Manufactured by: Strides Shasun Limited Beng...
Oral Drugs·2,576 affected·Feb 17, 2020
High RiskFDA
Beckman Coulter, Inc.
iChemVELOCITY Strips, Catalog 800-7212
Medical Devices·10,822 affected·Feb 17, 2020
High RiskFDA
Cj Foods Inc., A Division Of Cj America
Annie Chun's Japanese Style Teriyaki Noodle Bowl with Cooked Hokkien Noodles - Sweet & Tangy sauce with Bok choy and carrots. Noodles ar...
Beverages·33,900 affected·Feb 14, 2020
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Custom Foods Llc
Sticky Fingers Bakeries Gluten-Free Scones, Quick & Easy Mix, Meyer Lemon; Net Wt. 14 oz. (0.875 LBS) 396.9g. In Ingredient list: Lemo...
Food·7,344 affected·Feb 14, 2020
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Aaa Pharmaceutical, Inc.
Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg /Antihistamine, Indoor/Outdoor Allergies, 24 Hour, a) 30 t...
Oral Drugs·3,456 affected·Feb 14, 2020
CriticalFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
Medical Devices·1,050 affected·Feb 14, 2020
High RiskFDA
Icu Medical, Inc.
The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619...
Cardiac Devices·123 affected·Feb 14, 2020