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High RiskFDA
Hitachi Healthcare Americas Corp Informatics Division
VidiStar(TM) PACS & DICOM Viewer Software system
Medical Devices·12 affected·Aug 28, 2018
High RiskFDA
Ortho-clinical Diagnostics
VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantit...
Diagnostic Devices·6,630 affected·Aug 28, 2018
High RiskFDA
Stryker Gmbh
Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. Product Usage - The Hoffmann LRF System is indicated in pedi...
Medical Devices·832 affected·Aug 28, 2018
High RiskFDA
Abbott Laboratories, Inc
Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technology) is used fo...
Medical Devices·99 affected·Aug 28, 2018
High RiskFDA
Stryker Gmbh
Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. Product Usage - The Hoffmann LRF System is indicated in pedi...
Medical Devices·1,355 affected·Aug 28, 2018
High RiskFDA
Califia Farms Llc
Califia Farms 100% Arabica Coffee; Mocha Cold Brew Coffee with Almond Milk 48 fl. oz. plastic bottle. Dairy Free UPC: 85290900350...
Dairy·24,507 affected·Aug 24, 2018
High RiskFDA
Lgm Pharma Llc
Thyroid Powder, USP, 25kg/drum, Rx Only, Sichuan Friendly Pharmaceutical Co., LTD. NDC: 070870-1701-1
Drugs·1,307 affected·Aug 24, 2018
High RiskFDA
Valeant Pharmaceuticals North America Llc
Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bottle, OTC, Distributed by: Valeant Pharmaceuticals N...
Inhaled / Nasal Drugs·18,408 affected·Aug 24, 2018
High RiskFDA
Valeant Pharmaceuticals North America Llc
Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bri...
Topical Drugs·119,594 affected·Aug 24, 2018
High RiskFDA
Akorn, Inc.
Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA 30062. Mfg By: Swiss ...
Oral Drugs·23,788 affected·Aug 24, 2018
High RiskFDA
Remedyrepack Inc.
Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 7...
Oral Drugs·2 affected·Aug 24, 2018
High RiskFDA
Valeant Pharmaceuticals North America Llc
Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 g) tube, OTC, Distributed by: Valeant Pharmaceuticals No...
Topical Drugs·5,016 affected·Aug 24, 2018
High RiskFDA
Shinchang Medical Co., Ltd.
Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16. (10 syringes are packaged in a flexible plasti...
Diabetes Devices·6,570,800 affected·Aug 24, 2018
High RiskFDA
Life Technologies, Corp.
Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use
Diagnostic Devices·1,329 affected·Aug 24, 2018
High RiskFDA
Life Technologies, Corp.
Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061
Diagnostic Devices·1,912 affected·Aug 24, 2018
High RiskFDA
Vision Rt Ltd
Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) s...
Medical Devices·690 affected·Aug 24, 2018
High RiskFDA
Trimed Inc.
TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonst...
Medical Devices·5 affected·Aug 24, 2018
High RiskFDA
Life Technologies, Corp.
Gibco DPBS, calcium, magnesium, for In-Vitro Diagnostic Use SKU 14040141
Diagnostic Devices·240 affected·Aug 24, 2018
High RiskFDA
Life Technologies, Corp.
Gibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use
Diagnostic Devices·41 affected·Aug 24, 2018
High RiskFDA
Dewey's Bakery, Inc Dba Salem Baking Company
Dewey's BAKERY Soft Baked TRIPLE CHOCOLATE BROWNIE COOKIES NET WT. 6 OZ paper bag Dewey's BAKERY WINSTON-SALEM, NC 27103 (877) 339-3974 U...
Bakery & Grains·33,473 affected·Aug 23, 2018
High RiskFDA
Pfizer Global Supply
Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL OZ (120 ml) bottle, Pfizer, Madison, NJ 07940 USA, NDC 0573-0...
Oral Drugs·17,136 affected·Aug 23, 2018
High RiskFDA
Pacific Compounding Pharmacy & Consultations Inc
Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA
Drugs·41 affected·Aug 23, 2018
High RiskFDA
Tosoh Bioscience Inc
AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro diagnostic to prov...
Diagnostic Devices·1,228 affected·Aug 23, 2018
High RiskFDA
Stryker Sustainability Solutions
Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the...
Cardiac Devices·2 affected·Aug 23, 2018
High RiskFDA
Syntec Pharma Corp
THYROID POWDER USP (Levothyroxine labeled range of 34.2-41.8mcg/grain; Liothyroine (correct spelling Liothyronine): labeled range of 8.1-...
Drugs·486 affected·Aug 22, 2018
High RiskFDA
Syntec Pharma Corp
THYROID POWDER USP, Full Strength (Levothyroxine labeled range of 103-125mcg/grain; Liothyroine (correct spelling Liothyronine): labeled ...
Drugs·2 affected·Aug 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1030-12 Used for the re-attachment of t...
Medical Devices·11,580 affected·Aug 22, 2018
High RiskFDA
Safe N Simple, Llc
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345
Medical Devices·125 affected·Aug 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp Ref Number: 75-1040 Used for the re-attachment of the bone flap ...
Medical Devices·3,246 affected·Aug 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1040-12 Used for the re-attachment of the...
Medical Devices·6,180 affected·Aug 22, 2018
High RiskFDA
Lipari Foods Operating Company, Llc Dba Jlm Manufacturing
Premo Brand Turkey & Cheese Wedge sandwiches 5 OZ retail UPC 612510002018 Plastic triangle sandwich wedge container with plastic fil...
Dairy·3,448 affected·Aug 21, 2018
High RiskFDA
Auro Pharmacies, Inc.
Methyl-Cobalamin injectable, 1 mg/mL, packaged in a) 5 mL and b) 30 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy...
Injectable Drugs·114 affected·Aug 21, 2018
High RiskFDA
Baxter Healthcare Corporation
0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338-0049-18
Injectable Drugs·33,600 affected·Aug 21, 2018
High RiskFDA
Auro Pharmacies, Inc.
Methyl-Cobalamin injectable, 5 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Hab...
Injectable Drugs·90 affected·Aug 21, 2018
High RiskFDA
Auro Pharmacies, Inc.
Testosterone Cypionate/Enanthate injectable, 200/50 mg/mL, packaged in a) 5 mL and 8 mL Multiple Dose vials, Rx only, Central Drugs Compo...
Injectable Drugs·32 affected·Aug 21, 2018
High RiskFDA
Auro Pharmacies, Inc.
Glutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra,...
Injectable Drugs·183 affected·Aug 21, 2018
High RiskFDA
Sichuan Friendly Pharmaceutical Co.,ltd.
Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD, Production Address: No. 680, Hongpai Road, Dongxing...
Drugs·2,662 affected·Aug 21, 2018
High RiskFDA
Auro Pharmacies, Inc.
Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, ...
Injectable Drugs·91 affected·Aug 21, 2018
High RiskFDA
Auro Pharmacies, Inc.
CoEnzyme-Q10 injectable, 20 mg/mL, 10 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra,...
Injectable Drugs·39 affected·Aug 21, 2018
High RiskFDA
Auro Pharmacies, Inc.
Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Co...
Injectable Drugs·43 affected·Aug 21, 2018
High RiskFDA
Auro Pharmacies, Inc.
Methyl-Cobalamin injectable, 2 mg/mL, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Ha...
Injectable Drugs·74 affected·Aug 21, 2018
High RiskFDA
Auro Pharmacies, Inc.
Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Co...
Injectable Drugs·11 affected·Aug 21, 2018
High RiskFDA
Auro Pharmacies, Inc.
Folic Acid injectable, 10 mg/ml, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, ...
Injectable Drugs·40 affected·Aug 21, 2018
High RiskFDA
Auro Pharmacies, Inc.
Methyl-Cobalamin injectable, 10 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Ha...
Injectable Drugs·81 affected·Aug 21, 2018
High RiskFDA
Auro Pharmacies, Inc.
Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, C...
Injectable Drugs·167 affected·Aug 21, 2018
High RiskFDA
Origen Biomedical, Inc.
Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for u...
Medical Devices·73 affected·Aug 21, 2018
High RiskFDA
Genicon, Inc.
Genicon GENILook Model 200-005-152, 5mm diameter, 100mm legnth (2 cannula, threaded) - Product Usage: The universal handle can be used as...
Medical Devices·48 affected·Aug 21, 2018
High RiskFDA
Origen Biomedical, Inc.
Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for us...
Medical Devices·452 affected·Aug 21, 2018