06
February
0
Comments
Indian National Sentenced for Conspiracy to Distribute Controlled Substances
in FDA News
FDA-OCI, Burlington, Vermont, Nitin Mishra, Jaipur, India Read More (external link)...
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Author: Asebey Law
06
February
California Man Sentenced for Selling Unapproved Drugs with Intent to Defraud over the Internet
in FDA News
FDA-OCI, Burlington, Vermont, Jeremy Brown, Simi Valley, California, Warrior Labz SARMs Read More (external link)...
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06
February
Michigan Man Charged with Drug Distribution and Loan Fraud
in FDA News
FDA-OCI, Boston, Massachusetts, Michigan, Donald Nchamukong, Doyal Kalita Read More (external link)...
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06
February
Hell’s Kitchen Aesthetician Arrested For Unlawfully Injecting Counterfeit Botox
in FDA News
FDA-OCI, JGL Aesthetics, Manhattan, New York, Hell's Kitchen, Joey Grant Luther Read More (external link)...
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06
February
Turkana Food Inc. Recalls Aleppo Tahini Sesame Paste 1lb (16oz) Because of Possible Health Risk
in FDA News
Turkana Food Inc. Kenilworth, NJ is recalling 858 cases OF Aleppo Tahini Sesame Paste 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 others with weakened immune system Read More (external link)...
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06
February
Arterial Catheter Recall: Medline Industries, LP, Removes Integrated Arterial Catheters due to Excess Material at Catheter Hub that May Detach
in FDA News
Medline Integrated Arterial Catheters continuously monitor blood pressure. Excess material on the catheter hub that may detach and enter the patient. Read More (external link)...
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06
February
Early Alert: Atherectomy Catheter System Issue from Bard Peripheral Vascular
in FDA News
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program Read More (external link)...
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05
February
What is Trump’s Regulatory Freeze, and What Does It Mean for Federal Rulemaking?
On January 20, 2025, President Trump issued an executive memorandum announcing a “regulatory freeze” that pauses all federal rulemaking activities across executive departments and agencies. Key highlights include: No New Rules Proposed or final rules cannot move forward until reviewed and approved by an appointee designated by the President. Exceptions may apply for emergencies or urgent circumstances, such as those with statutory or judicial deadlines, as determined by the Director or Acting Director of the White House’s Office of Management and Budget (OMB). Immediate Withdrawal Any rules submitted to the Federal Register but not yet published, or issued in any manner but not yet...
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05
February
Oxygen Concentrator Recall: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD Removes JMC5A Ni/TruAire-5 Oxygen Concentrator due to the devices spontaneously catching fire
in FDA News
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD is recalling certain devices due to incidents of device melting and fire during the use of oxygen concentrators. Read More (external link)...
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05
February
Continuous Ventilator Correction: Baxter Healthcare Corporation Issues Correction for Life2000 Ventilator due to a nonconforming battery charger, which triggers a battery alarm and renders the ventilator inoperable
in FDA News
Baxter Healthcare is recalling the Life2000 Ventilator System by correction, due to a defective battery charger making the ventilator inoperable. Read More (external link)...
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05
February
FDA Alerts Patients to Regularly Check Diabetes-Related Smartphone Device Alert Settings, Especially Following Phone Hardware or Software Changes
in FDA News
The FDA is alerting users of diabetes-related medical devices that smartphones connected to diabetes devices may fail to send critical safety alerts. Read More (external link)...
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03
February
Introducing the Life Sciences Law Blog
Welcome to the Life Sciences Law blog — your resource for legal insights, regulatory developments, and policy trends shaping the life sciences industry today. In this space, we’ll explore how key issues impact FDA-regulated companies as well as the cannabis, hemp, and psychedelics industries. Writing about science and law is what we love to do. We’re not just here tracking headlines; We’re translating them into practical takeaways through a thoughtful perspective. Whether it’s exploring how biotech companies tackle clinical trial design, analyzing the latest developments in compounded GLP-1 regulations, or discussing emerging trends in psychedelics and cannabis, understanding not just what’s happening...
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03
February
Pressure Monitoring Device Recall: Medtronic Neurosurgery Issues Correction for Becker and Exacta External Drainage and Monitoring Systems Due to Cracks And/Or Leaks in Stopcocks
in FDA News
Becker and Exacta EDMS are used for draining and monitoring cerebrospinal fluid in the brain. Stopcocks may have cracks or leaks that pose a risk to patients. Read More (external link)...
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31
January
Gerber Products Company Announces Recall and Discontinuation of All Batches of Gerber® Soothe N Chew® Teething Sticks Due To Choking Hazard
in FDA News
January 31, 2025 — Gerber Products Company is initiating a recall and discontinuation of all batches of GERBER® SOOTHE N CHEW® TEETHING STICKS due to a potential choking hazard for babies and young children Read More (external link)...
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31
January
Alvogen Issues Voluntary Nationwide Recall for One Lot of Fentanyl Transdermal System 25 mcg/h Due to a Defective Delivery System
in FDA News
Alvogen, Inc. is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches to the consumer level. The reason for the recall is that there is a potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch. This transdermal s Read More (external link)...
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31
January
Blue Ridge Beef Issues a Recall of Blue Ridge Beef Natural Mix Due to Salmonella Contamination
in FDA News
January 31, 2025– Blue Ridge Beef is recalling 5,700 lbs. of their 2 lb log Natural Mix due to a contamination of Salmonella. Lot # N25/12/31 (Lot numbers are stamped in the clips on the end of the chubs/bags) UPC# 854298001054. Read More (external link)...
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31
January
Gas Powered Emergency Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitator Due to An Undersized Spring in The Controller That May Prevent the Device from Delivering the Required Pressure Levels Needed for Effective Ventilation
in FDA News
Mercury Medical recalls the Neo-Tee T-Piece Resuscitator due to the controller potentially not delivering the pressure levels needed for effective ventilation. Read More (external link)...
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31
January
Update on Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus
in FDA News
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program Read More (external link)...
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31
January
Update on Alert: Infusion Pump Issue from Fresenius Kabi USA
in FDA News
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program Read More (external link)...
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31
January
Update on Alert: Nephroscope Sheath Issue from Trokamed GmbH
in FDA News
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program Read More (external link)...
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