Author: Asebey Law

08 July

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Natureen International Inc. Recalls Wei-Chuan Dried Black Fungus Slice (2.5oz) Because of Possible Health Risk

Posted by Asebey Law

Natureen International Inc. of Walnut, CA is recalling 244 bags of Wei-Chuan Dried Black Fungus Slice (2.5oz / bag), because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and oth Read More (external link)...

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08 July

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Black Horse Miracle Honey for Men may be harmful due to hidden drug ingredients

Posted by Asebey Law

The Food and Drug Administration is advising consumers not to purchase or use Black Horse Miracle Honey for Men, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. Read More (external link)...

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08 July

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Secret Miracle Honey Extra Strength may be harmful due to hidden drug ingredients

Posted by Asebey Law

The Food and Drug Administration is advising consumers not to purchase or use Secret Miracle Honey Extra Strength, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. Read More (external link)...

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08 July

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Black Panther Miracle Honey for Men may be harmful due to hidden drug ingredients

Posted by Asebey Law

The Food and Drug Administration is advising consumers not to purchase or use Black Panther Miracle Honey for Men, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. Read More (external link)...

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08 July

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Versace Real Honey for Men may be harmful due to hidden drug ingredients

Posted by Asebey Law

The Food and Drug Administration is advising consumers not to purchase or use Versace Real Honey for Men, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. Read More (external link)...

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01 July

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Early Alert: Infusion Pump Software Issue from Baxter

Posted by Asebey Law

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program Read More (external link)...

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01 July

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Early Alert: Blood Pump Controller Issue from Abiomed

Posted by Asebey Law

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program Read More (external link)...

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01 July

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Extended-Release Stimulants for ADHD: FDA Drug Safety Communication – FDA Requires Expanded Labeling about Weight Loss Risk in Patients Younger than 6 Years

Posted by Asebey Law

The FDA is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD) - including certain formulations of amphetamine and methylphenidate - to warn about the risk of weight loss and other adverse reactions (side effects) in patients yo Read More (external link)...

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27 June

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Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging

Posted by Asebey Law

Sandoz, Inc. (“Sandoz”) is initiating a voluntary recall of one (1) lot of Cefazolin for Injection, USP, 1 gram per vial. Read More (external link)...

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26 June

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Shang Hao Jia, Inc. Issues Allergy Alert on Undeclared Sesame in Danshi Brand Spicy Shredded Tofu

Posted by Asebey Law

Shang Hao Jia, Inc. of South El Monte, CA is recalling 50 case of Danshi brand Spicy Shredded Tofu, because it may contains undeclared sesame. Read More (external link)...

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25 June

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Mellace Family Brands California, Inc. Issues An Allergy Alert On Undeclared Milk Allergen In Wegmans Semi-Sweet Chocolate Nonpareils

Posted by Asebey Law

Mellace Family Brands California, Inc. of Warren, OH is recalling Wegmans Semi – Sweet Chocolate Nonpareils, because they contain undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this prod Read More (external link)...

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25 June

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Kilwins Quality Confections, LLC. Issues Allergy Alert on Undeclared Pecans in Mocha Truffles

Posted by Asebey Law

Kilwins Quality Confections, LLC., of Petoskey, Michigan, is voluntarily recalling Mocha Truffles because they may contain undeclared pecans. Read More (external link)...

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25 June

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Angiographic Catheter Recall: Cook Removes Beacon Tip Angiographic Catheters due to Tip Separation

Posted by Asebey Law

Affected device lots may experience tip separation; field complaints reported that the tip separation can occur both prior to and during patient contact. Read More (external link)...

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25 June

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mRNA COVID-19 Vaccines: FDA Safety Communication – FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination

Posted by Asebey Law

mRNA COVID-19 Vaccines: FDA Safety Communication - FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination Read More (external link)...

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24 June

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Import Alerts for Certain Olympus Medical Devices Manufactured in Japan – Letter to Health Care Providers

Posted by Asebey Law

The U.S. Food and Drug Administration (FDA) is alerting health care providers about import alerts for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation (Olympus) and its subsidiaries. Read More (external link)...

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24 June

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Early Alert: Esophageal pH Monitoring Capsule Issue from Medtronic

Posted by Asebey Law

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program Read More (external link)...

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23 June

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Transderm Scōp (Scopolamine Transdermal System): Drug Safety Communication – FDA Adds Warning About Serious Risk of Heat-Related Complications with Antinausea Patch

Posted by Asebey Law

The FDA is warning that the antinausea patch Transderm Scōp (scopolamine transdermal system) can increase body temperature and cause heat-related complications, resulting in hospitalization or even death in some cases. Most cases occurred in children 17 years and younger and in adults 60 years and o Read More (external link)...

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23 June

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Medical Procedure Kits Correction: Medline Industries, LP Issues Correction for Medline Procedure Kits Containing Medtronic Aortic Root Cannula due to Potential Excess Material in Male Luers

Posted by Asebey Law

Medline Industries is correcting certain lots of their medical procedure kits that contain a recalled Medtronic aortic root cannula Read More (external link)...

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23 June

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Anesthesia Delivery Systems Recall: GE HealthCare Issues Correction for Certain Carestations due to Risk of Ineffective Ventilation When Used in Volume Control Ventilation (VCV) Mode 

Posted by Asebey Law

GE HealthCare is correcting Carestations that may not ventilate properly in VCV mode. The issue is clearly indicated by alarms; other modes remain effective. Read More (external link)...

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23 June

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Resuscitation System Recall: ZOLL Circulation, Inc. Recalls AutoPulse NXT Resuscitation System Due to a Failure Code That May Stop Compressions or Deliver Inadequate CPR

Posted by Asebey Law

Recall: ZOLL Circulation, Inc. Recalls AutoPulse NXT Resuscitation System Due to a Failure Code That May Stop Compressions or Deliver Inadequate CPR Read More (external link)...

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