Medical Devices and Pharma
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FDA Alert: Baxter Recalls Spectrum Infusion Pumps
Baxter Spectrum Infusion Pump Alert Date: July 2025Device: Sigma Spectrum Infusion System (V6 and V8 Platforms)Manufacturer: Baxter HealthcareIssue Type: Urgent Medical Device RecallFDA Status: High-risk; active monitoring in progress The FDA has issued an early alert...
Urgent Recall: Dr. Reddy’s Levetiracetam Injection
What You Need to Know Dr. Reddy’s Laboratories has issued an urgent recall for one batch (Lot No: A1540076) of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL due to a serious labeling error. The infusion bag is incorrectly labeled as Levetiracetam...
FDA Issues Warning on Epinephrine Nasal Solutions
Left: BPI Labs’ FDA-approved Epinephrine Injection with blue lid on the bottle.Right: BPI Labs’ unapproved EPINEPHrine Chloride Nasal Solution with red lid on the bottle.Courtesy: FDA.A Potentially Dangerous Mix-Up The U.S. Food and Drug Administration (FDA) has...
FDA Issues Warning on Counterfeit Botox Products
Real Botox PackagingReal Botox Cosmetic PackagingReal Botox PackagingCounterfeit Botox Products The U.S. Food and Drug Administration (FDA) has issued a critical alert concerning the presence of counterfeit Botox products in various states, posing severe risks to...
FDA Cracks Down on Insightra Medical
Warning Letter Cites a Number of Serious Violations In a scathing warning letter, the FDA has cited Insightra Medical, Inc. for widespread regulatory violations involving its Intra-Aortic Balloon Pump (IABP) Catheter Kit—a device used in critical cardiovascular...
Mechanical Circulatory Support (MCS) Devices
Overview of MCS Devices Mechanical Circulatory Support (MCS) devices have transformed the landscape of advanced heart failure treatment. From temporary stabilization in cardiogenic shock to long-term support as destination therapy, these technologies bridge critical...
Recall Alert: AirLife/Vyaire Infant Breathing Systems
Class I Recall AirLife and manufacturer Vyaire are recalling specific Infant Heated Wire Circuits due to the risk that accessory adapters may disconnect during use, especially once the system reaches operating temperature. This could lead to serious injury or death,...
Avanos Recalls Ballard Closed Suction Systems
May result in non-sterile devices Avanos Medical, Inc. is recalling its Ballard Closed Suction Systems after identifying a failure in the sterilization process, which may result in non-sterile devices. Use of these products could lead to serious health risks,...
Generic Eliquis
Generic Eliquis Editor's note: FDA originally announced the approval of generic equivalents to Eliquis in 2019, and updated that information the next year. We are publishing this information as a response to reader requests for more information about generic Eliquis....
FDA Grants Accelerated Approval to Tarlatamab-dlle
Treatment for lung cancer with progression following platinum-based chemotherapy On May 16, 2024, the Food and Drug Administration (FDA) granted accelerated approval to Imdelltra (tarlatamab-dlle) manufactured by Amgen, Inc. for the treatment of extensive stage small...
FDA Approves New Imaging Drug Lumisight
A Significant Improvement for Surgical Oncology The U.S. Food and Drug Administration (FDA) has granted approval to LumiSight (pegulicianine) for use in adults undergoing breast lumpectomy, marking a significant advancement in surgical oncology. Lumisight, a...
FDA Issues Warning on Counterfeit Botox Products
Real Botox PackagingReal Botox Cosmetic PackagingReal Botox PackagingCounterfeit Botox Products The U.S. Food and Drug Administration (FDA) has issued a critical alert concerning the presence of counterfeit Botox products in various states, posing severe risks to...
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How U.S. Testosterone Regulation Reached a Crossroads
How U.S. Testosterone Regulation Reached a Crossroads The FDA’s approach to testosterone therapy has undergone one of the most unusual and dramatic evolutions in modern drug regulation. What began as a cautious, evidence-driven posture in 2014 has, by late 2025,...
Has Industry Self-Regulation Been Effective?
Has Industry Self-Regulation Been Effective? Supplement industry self-regulation has helped in limited ways, but it has not been sufficient to ensure reliable safety. What has worked Voluntary GMP certifications (e.g., NSF, USP, Informed Choice) A minority of...
Why DSHEA Reform Must Be a Priority
Why DSHEA Reform Must Be a Priority The recent wave of moringa-related contamination recalls – touching national retail chains and rippling through dozens of contract manufacturers – has forced an uncomfortable question into public view: How was a single tainted...
The 30-Year Consequences of Faulty Supplement Legislation
How a 1994 Law Created Today’s Dietary Supplement Crisis In light of the current moringa contamination recalls affecting national retailers and dozens of downstream manufacturers, many consumers are asking the same question: How did this happen? The answer leads us...
FDA Recalls “Sexual Enhancement” Supplements
FDA Recall Highlights Ongoing Risks of Adulterated “Sexual Enhancement” Supplements Pure Vitamins and Natural Supplements,...
FDA’s AEMS: Real-Time Drug and Device Safety Monitoring
FDA’s AEMS: The Beginning of Real-Time Drug and Device Safety MonitoringThe U.S. Food and Drug Administration has launched...
When Randomized Trials Are Not Possible
When Randomized Trials Are Not Possible: How Real-World Evidence Is Shaping FDA Drug Approvals The U.S. Food and Drug...
FDA Approves Cerebral Folate Transport Deficiency Treatment
FDA Approves First Treatment for Cerebral Folate Transport Deficiency The U.S. Food and Drug Administration (FDA) has...
FDA Streamlines Biosimilar Development to Reduce Drug Costs
FDA Moves to Streamline Biosimilar Development and Reduce Drug Costs The U.S. Food and Drug Administration (FDA) has...
FDA Inspections for Domestic and Foreign Device Manufacturers
Early Observations: Comparing FDA Inspection OutcomesStriking Difference in Inspection Outcomes for Domestic and Foreign...
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.
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