Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationFDA and global regulatory affairs, consumer health, and professional development
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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...
GE HealthCare Anesthesia Systems Recall Due to Ventilation Risk
GE Carestation Anesthesia Systems GE HealthCare has issued a high-priority correction for certain Carestation anesthesia systems due to a potentially life-threatening risk when used in Volume Control Ventilation (VCV) mode. Affected Devices Carestation 620, 650, 650c...
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...
The Role of a Regulatory Professional
510(k) Submissions The New QSMR Regulatory Intelligence RIM Systems Regulatory Competencies Regulatory and Quality Role of Regulatory Professionals: Core Responsibilities Regulatory professionals play a critical role in ensuring that medical devices and pharmaceutical...
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...
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....
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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...
Organic Moringa Powder Recalled for Salmonella Contamination
On November 12, organic moringa powder importer and packager Africa Imports issued a recall notice for its products dating back to June 5. The recall notice was published on the FDA website. Following are details of the recall. Who Issued the Recall Africa Imports...
EU Notified Bodies
Role, Responsibilities, and Strategic Considerations for Medical Device Manufacturers Notified Bodies (NBs) are independent...
FDA Approves First Generic for Equine Gastric Ulcers
FDA Approves First Generic Omeprazole Paste for Gastric Ulcers in Horses The U.S. Food and Drug Administration has approved...
FDA Class I Recall for Abiomed Impella Gen 1 Purge Cassettes
Medical Device Alert: Abiomed Impella Purge Cassette Recall (Class I) Abiomed has initiated a Class I recall, the most...
Class I Correction for Abiomed Impella Inaccurate Flow Readings
Abiomed Impella RP: FDA Class I Correction for Inaccurate Flow Readings Abiomed has issued an Urgent Medical Device...
Class I Correction for Homecare Bed Fire and Entrapment Risks
Medline Homecare Beds: FDA Class I Correction for Fire and Entrapment Risks Medline Industries has issued a critical safety...
Nivolumab Combination Therapy for Advanced Hodgkin Lymphoma
FDA Approves Nivolumab Combination Therapy for Advanced Hodgkin Lymphoma On March 20, 2026, the U.S. Food and Drug...
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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