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High RiskFDA
Crown Prince, Inc
Crown Prince Quality Natural Seafood Smoked Baby Clams Hand Packed in Olive Oil From Managed Fisheries NET WT. 3 oz. (35g) UPC 0 73230 00...
Seafood·211,716 affected·Jul 15, 2022
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufactured by: Cadila...
Injectable Drugs·1,116 affected·Jul 15, 2022
High RiskFDA
Aire-master Of America Inc
Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 08734
Drugs·4 affected·Jul 15, 2022
High RiskFDA
Vi-jon, Llc
Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 FL OZ (296 mL), a) CVS Health UPC 0 50428 33517 8 or UPC 0 5...
Oral Drugs·22,965,330 affected·Jul 15, 2022
High RiskFDA
Vi-jon, Llc
Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Grape Flavor, 10 FL OZ (296 mL), a) Best Choice UPC 0 70038 66220 4 Proudly D...
Oral Drugs·8,064,834 affected·Jul 15, 2022
High RiskFDA
Aire-master Of America Inc
Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tamp...
Drugs·960 affected·Jul 15, 2022
High RiskFDA
Aire-master Of America Inc
Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 33606
Drugs·5,064 affected·Jul 15, 2022
High RiskFDA
Aire-master Of America Inc
Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa...
Drugs·9,176 affected·Jul 15, 2022
High RiskFDA
Vi-jon, Llc
Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Cherry Flavor, 10 FL OZ (296 mL), a) Best Choice UPC 0 70038 58790 3 Proudly ...
Oral Drugs·10,070,526 affected·Jul 15, 2022
High RiskFDA
Aire-master Of America Inc
Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum, Fragrance F...
Drugs·18 affected·Jul 15, 2022
High RiskFDA
Aire-master Of America Inc
Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct...
Drugs·4,632 affected·Jul 15, 2022
High RiskFDA
Aesculap Implant Systems Llc
Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic a...
Medical Implants·6 affected·Jul 15, 2022
High RiskFDA
Deroyal Industries Inc
DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick R...
Medical Devices·36 affected·Jul 15, 2022
High RiskFDA
Ge Healthcare, Llc
(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Vi...
Medical Devices·1,690 affected·Jul 15, 2022
High RiskFDA
Factor
Factor Shrimp & Asparagus Risotto with pesto green beans 14.2oz.
Seafood·6,897 affected·Jul 14, 2022
High RiskFDA
Factor
Factor Sweet Pea Risotto & Roasted Brussel Sprouts 17.6 oz.
Food·849 affected·Jul 14, 2022
High RiskFDA
Kabobs Acquisition Inc.
Kabobs The Hors d'oeuvre Specialist TOMATO, BASIL & MASCARPONE ARANCINI 180 COUNT Prepared by: Kabobs, Inc., 5423 North Lake Dr., Lake Ci...
Produce·98 affected·Jul 14, 2022
High RiskFDA
Factor
Factor Vegan Mushroom Marsala with onion risotto & roasted garlic green beans 12.7oz
Produce·48,962 affected·Jul 14, 2022
High RiskFDA
Factor
Factor Summertime Filet & Sweet Corn Risotto with Sweet Peach-Berry Crumble & Zucchini Medley 15.2oz.
Produce·10,545 affected·Jul 14, 2022
High RiskFDA
Kabobs Acquisition Inc.
Kabobs The Hors d'oeuvre Specialist TRUFFLE ARANCINI WITH WILD MUSHROOMS 180 COUNT Prepared by: Kabobs, Inc., 5423 North Lake Dr., Lake C...
Food·112 affected·Jul 14, 2022
High RiskFDA
Factor
Factor Tomato & Roasted Vegetable Risotto with toasted pine nuts 12.6oz.
Produce·23,439 affected·Jul 14, 2022
High RiskFDA
Factor
Factor Caramelized Onion & Goat Cheese Risotto with Roasted Carrots 13.5oz
Dairy·58,020 affected·Jul 14, 2022
High RiskFDA
Cipla
Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies Limited., L-32, 33, 34,...
Ophthalmic Drugs·8,136 affected·Jul 14, 2022
High RiskFDA
Baxter Healthcare Corporation
The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to co...
Medical Devices·448,960 affected·Jul 14, 2022
High RiskFDA
Aesculap Implant Systems Llc
Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
Medical Devices·5 affected·Jul 14, 2022
High RiskFDA
Philips Ultrasound, Llc
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232,...
Medical Devices·1,721 affected·Jul 14, 2022
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas e801 Immunoassay Analyzer
Diagnostic Devices·965 affected·Jul 14, 2022
High RiskFDA
Luminex Corporation
ARIES SARS-CoV-2 Assay
Diagnostic Devices·257 affected·Jul 14, 2022
High RiskFDA
Woodland Foods Llc
Woodland Ingredients X06D Arborio Rice, 25 lbs. bag UPC 00687080007374 Woodland Ingredients X16D Italian Arborio Rice, 25 lbs. bag UPC 00...
Food·2,299 affected·Jul 13, 2022
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx Only, D...
Oral Drugs·2,892 affected·Jul 13, 2022
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx Only, D...
Oral Drugs·2,639 affected·Jul 13, 2022
High RiskFDA
Biomerieux, Inc.
VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9
Medical Devices·0 affected·Jul 13, 2022
High RiskFDA
The Procter & Gamble Company
Vicks Children's Botanicals Liquid Nighttime 4oz plastic bottle
Food·18,490 affected·Jul 12, 2022
High RiskFDA
The Procter & Gamble Company
Vicks ZzzQuil Liquid Melatonin Syrup Adult 8oz plastic bottle sold as single and twin pack
Food·90,522 affected·Jul 12, 2022
High RiskFDA
The Procter & Gamble Company
Vicks ZzzQuil Liquid Melatonin Syrup Pediatric 8oz plastic bottle sold as single and twin pack
Food·60,778 affected·Jul 12, 2022
High RiskFDA
The Procter & Gamble Company
Vicks Children's Botanicals Liquid Daytime/Nighttime Combo Pack 4oz plastic bottles
Food·82,433 affected·Jul 12, 2022
High RiskFDA
The Procter & Gamble Company
Vicks Children's Botanicals Liquid Daytime 4oz plastic bottle
Food·34,526 affected·Jul 12, 2022
High RiskFDA
Fujifilm Healthcare Americas Corporation
Surpria 64: Software Version V3.11, V3.22
Medical Devices·16 affected·Jul 12, 2022
High RiskFDA
Fujifilm Healthcare Americas Corporation
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
Medical Devices·46 affected·Jul 12, 2022
High RiskFDA
Hikma Pharmaceuticals Usa Inc.
Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07...
Injectable Drugs·301,400 affected·Jul 11, 2022
High RiskFDA
Tolmar, Inc.
Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g tube (NDC 0115-1510-48), b) Net Wt. 40g tube (NDC 0115-1510...
Topical Drugs·1,271 affected·Jul 11, 2022
High RiskFDA
Hikma Pharmaceuticals Usa Inc.
Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Ca...
Injectable Drugs·713,550 affected·Jul 11, 2022
High RiskFDA
Hikma Pharmaceuticals Usa Inc.
Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Ca...
Injectable Drugs·82,700 affected·Jul 11, 2022
High RiskFDA
Hikma Pharmaceuticals Usa Inc.
Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 06...
Injectable Drugs·4,739,000 affected·Jul 11, 2022
High RiskFDA
Wissner-bosserhoff Gmbh
SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198
Medical Devices·77 affected·Jul 11, 2022
High RiskFDA
Oculus Optikgeraete Gmbh
Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
Medical Devices·92 affected·Jul 8, 2022
High RiskFDA
Refresco Beverages Us Inc
Clear American brand "Strawberry Punch Snow Cone" flavored sparkling water beverage with other natural flavors; 1-liter clear plastic bot...
Beverages·87 affected·Jul 7, 2022
High RiskFDA
Portland Specialty Baking Llc
Lemon Muffins, item # 802387, are packaged in paper tray and covered with plastic film shrink wrap. Each tray contains 6 pieces and ther...
Food·160 affected·Jul 7, 2022