Medical Devices and Pharma
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FDA Announces Recall of GE Nuclear Medicine Systems
1200-pound Devices Could Fall on Patients On February 15, the FDA issued a statement announcing a recall of certain nuclear medicine systems manufactured by GE Healthcare. The recall involves the 600/800 Series nuclear medicine systems, which are used to diagnose and...
FDA announces recall of LivaNova LifeSPARC System
The US Food and Drug Administration (FDA) has announced a recall of the Livanova TandemLife LifeSparc System, a medical device used for circulatory support during heart surgery. The recall was initiated due to the potential for the device to experience unintentional...
Hospira Recalls Antibiotic for Presence of Glass Particles
Hospira, Inc., a division of Pfizer, announced a Class I recall of its Vancomycin Injection product due to visible glass particles that were identified in one vial of the drug. The recall involves lot 33045BA of Vancomycin Hydrochloride Injection USP 1.5g single dose...
Three Companies Recall Blood Pressure Medication
All recalled products had unacceptable levels of nitrosamines Three pharmaceutical manufacturers have recalled batches of the blood pressure drug quinapril this year for exceeding safe levels of nitrosamines. Luprin Pharmaceuticals, Aurobindo Pharma USA, and Pfizer...
FDA’s Orphan Drug Program
Expedite Development of New Orphan Drugs The FDA's Orphan Drug Program is designed to encourage the development of drugs and biologics for the treatment, diagnosis, or prevention of rare diseases or conditions, often referred to as orphan diseases. Here are the key...
Medical Devices and Pharmaceuticals
At Medical Devices and Pharma, we specialize in providing top-tier regulatory consulting services tailored to the medical device and pharmaceutical industries. Our deep understanding of policy, laws, regulations, and industry standardsand requirements will ensure your...
Risks with Exactech Equinoxe Shoulder System
FDA Safety Communication April 19 Update: Exactech has initiated a recall to remove Equinoxe Shoulder System devices packaged in the defective bags from facilities’ unused inventory. To see if your device is affected by the recall, visit Exactech’s Recall...
Important Recall Notice for BioMérieux VITEK 2 AST Kit
Class I Recall Notice BioMérieux Inc. has issued a crucial recall notice for its VITEK 2 AST kit, a vital tool in determining bacterial susceptibility to antibiotics. The Food and Drug Administration (FDA) classifies this recall as Class I, indicating a severe risk...
FDA Approves Lamzede for Treatment of Alpha-mannosidosis
The U.S. Food and Drug Administration (FDA) on February 17, 2023 announced the approval the first-ever enzyme replacement therapy (ERT) for the treatment of rare alpha-mannosidosis, a genetic disorder that affects an individual's ability to break down complex sugars....
FDA Approves Rukabia for HIV Treatment
The U.S. Food and Drug Administration (FDA) on December 22, 2022 announced the approval of a new HIV drug called Rukobia (fostemsavir) for adults living with HIV who have limited treatment options. This drug is the first in a new class of HIV medications known as...
FDA Warning Letter to Jackson Clinic
Warning Letter Sites Violations of Law In early February of this year, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Jackson Health & Wellness Clinic. The business was cited for several violations related to its marketing and...
FDA Accelerated Approval for Alzheimer’s Disease Treatment
The US Food and Drug Administration (FDA) announced on 06 January, 2023 that it had granted accelerated approval for the Alzheimer's disease treatment Leqembi. This is a significant milestone in the fight against Alzheimer's, a debilitating and progressive brain...
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Urgent Recall Notice for ARROW QuickFlash Catheterization Kits
Urgent Recall Notice for ARROW QuickFlash Catheterization Kits In February 2024, Teleflex and its subsidiary Arrow International issued an urgent recall notice for the ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits. Today, a...
Original FDA Safety Warning for China-made Syringes
In an announcement dated November 30, 2023, the U.S. Food and Drug Administration (FDA) issued a notice regarding the evaluation of potential device failures associated with plastic syringes manufactured in China. The FDA is actively collecting and analyzing data to...
AvKARE Recalls Atovaquone Oral Suspension
AvKARE Recalls Atovaquone Oral Suspension AvKARE, LLC has issued a voluntary recall of lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL due to potential Bacillus cereus contamination found during stability testing at a third-party lab. The affected...
FDA Warns of Risks with OTC Pain Relief Products
The U.S. Food and Drug Administration (FDA) has issued a stern warning to consumers regarding the use of certain over-the-counter analgesic (pain relief) products intended for topical use before, during, or after various cosmetic procedures like microdermabrasion,...
Now the Salmonella in Moringa Is Drug-Resistant
Now the Salmonella in Moringa Is Drug-Resistant. That Changes the Stakes. An MDP Consumer and Industry Brief Salmonella...
Why These Salmonella Outbreaks Keep Happening
Why These Salmonella Outbreaks Keep Happening: “Illness First, Controls Later” An MDP Consumer and Industry Brief When...
Four Moringa-Linked Salmonella Events in Four Months
Four Moringa-Linked Salmonella Events in Four Months: The Timeline That Should Not Exist An MDP Consumer and Industry Brief...
Moringa and the “Invisible Outbreak” Problem
Moringa and the “Invisible Outbreak” Problem in Supplements An MDP Consumer and Industry Brief Most Americans assume...
Rosabella Moringa Capsules Potential Salmonella Contamination
Rosabella Moringa Capsules Recalled Over Possible Salmonella Contamination Editor's Note: This February 13 recall is the...
Why Not Natural Organic Moringa Capsules Recalled
Why Not Natural Organic Moringa Capsules Recalled Over Possible Salmonella Contamination Editor's Note: This January 28...
Welcome to Medical Devices and Pharma, a website dedicated to providing timely and relevant medical device and pharma information to the regulated medical device and pharmaceutical industries, and consumers of those products.
Our goal is to provide organized, clearly written information from regulatory affairs and consumer perspectives.
- Key information from the Food and Drug Administration (FDA), the federal regulatory agency responsible for providing oversight over the industries and assuring the safety and efficacy of their products.
- Regulatory services for compliance, market access, and crisis management
- Information about innovation, including new products cleared for use in the U.S. market.
- News stories with topics ranging from product issues to market trends.
Perhaps most importantly, we will strive to maintain vigilance over product issues and their impacts. Check back here for consumer news, product alerts, and current litigation.
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