Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationHeadlines
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...
Health Alert Regarding Rare Pregnancy Complication
FDA Safety Communication In a recent health safety alert, the U.S. Food and Drug Administration (FDA) has cautioned healthcare professionals about the rare risk of intrahepatic cholestasis of pregnancy (ICP) associated with the use of thiopurines, including...
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...
How Unsafe Medical Devices Can Slip Through the Cracks
Healthcare professionals and the device industry share responsibility for timely adverse event reportingGlobal device market withdrawals not always followed in US In a world of global trade and instant communication, you might assume that a medical device deemed...
Study Reveals Delays in Medical Device Adverse Event Reporting
Healthcare professionals and the device industry share responsibility for timely adverse event reportingLapses defeat the purpose of adverse event reporting A recent study published in the British Medical Journal has spotlighted a troubling trend: many medical device...
A QSR to QMSR Transition Strategy
QMSR Implementation Strategy for U.S. Medical Device Manufacturers Not in Compliance with ISO 14385:2016 Transitioning from the FDA’s Quality System Regulation (QSR; 21 CFR 820) to the Quality Management System Regulation (QMSR) is a significant undertaking that...
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...
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...
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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...
Invisible Outbreak of Contaminated Supplement Ingredients
Contaminated Products Distributed Nationwide How a contaminated Moringa shipment was spread across the U.S. supplement market, and why there were no additional recalls. Sam’s Club announced a recall of its Member’s Mark Super Greens powder in late October 2025 due...
Latest Posts
FDA Approves First Oral Treatment for Canine Lymphoma
Approval Granted With Minor Use/Major Species (MUMS) Pathway The U.S. Food and Drug Administration has granted full approval to Laverdia® (verdinexor tablets), the first FDA-approved oral treatment for lymphoma in dogs. Canine lymphoma is a cancer of the lymph nodes...
FDA Grants Full Approval for Canine Epilepsy Drug
Approval Granted After Expanded Conditional Pathway The U.S. Food and Drug Administration has granted full approval to KBroVet® (potassium bromide chewable tablets) for the control of seizures in dogs diagnosed with idiopathic epilepsy, a chronic seizure disorder with...
FDA Advisory for Contaminated Raaw Energy Dog Food
The U.S. Food and Drug Administration (FDA) has issued a public advisory warning pet owners not to feed eight identified lots of Raaw Energy dog food after testing confirmed contamination with multiple pathogenic bacteria, including Listeria monocytogenes, Salmonella,...
FDA Approves First Generic Fenbendazole Oral Suspension
Defendazole™ (fenbendazole) 10% Oral Suspension The U.S. Food and Drug Administration has approved Defendazole™ (fenbendazole) 10% oral suspension, the first FDA-approved generic fenbendazole dewormer for use in beef and dairy cattle and goats. Defendazole is...
FDA Approves First Generic for Bovine Respiratory Disease
nixiFLOR, the first generic version of Resflor GOLD The U.S. Food and Drug Administration has approved nixiFLOR, an injectable solution combining florfenicol and flunixin meglumine, for the treatment of bovine respiratory disease (BRD) and the control of...
FDA Approves Drug to Delay Canine Congestive Heart Failure
Vetmedin is the first drug to go from an expanded conditional approval to fully approved The U.S. Food and Drug Administration has fully approved a new use for Vetmedin (pimobendan) chewable tablets, making it the first drug officially recognized to delay the onset of...
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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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