Medical Devices and Pharma
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FDA Closes Moringa Salmonella Outbreak Investigation
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention have concluded their investigation into a multistate Salmonella Typhimurium outbreak linked to MOGO-brand moringa powder capsules distributed by MOGO Moringa LLC of St. Louis,...
FDA Early Alert for Baxter Intravascular Administration Sets
Healthcare facilities are instructed to immediately stop using affected IV solution sets while FDA evaluates the potentially high-risk device issueThe U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding certain Baxter Duo-Vent Solution Sets...
Class I Recall for Bolton Medical RelayPro Thoracic Stent Graft
FDA Issues Class I Recall for RelayPro Thoracic Stent Graft Following Three Patient DeathsDeployment failure during aortic repair may require emergency open surgery The U.S. Food and Drug Administration (FDA) has issued a Class I recall for certain RelayPro Thoracic...
Arrow Corrects Kits With Recalled Injectable Medications
FDA Classifies Field Correction As Class I Recall Due to Risk of Serious Injury The U.S. Food and Drug Administration (FDA) has classified a correction issued by Arrow International, a subsidiary of Teleflex, as a Class I recall after certain convenience kits were...
FDA Early Alert for Baxter Intravascular Administration Sets
Healthcare facilities are instructed to immediately stop using affected IV solution sets while FDA evaluates the potentially high-risk device issueThe U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding certain Baxter Duo-Vent Solution Sets...
Class I Recall for Bolton Medical RelayPro Thoracic Stent Graft
FDA Issues Class I Recall for RelayPro Thoracic Stent Graft Following Three Patient DeathsDeployment failure during aortic repair may require emergency open surgery The U.S. Food and Drug Administration (FDA) has issued a Class I recall for certain RelayPro Thoracic...
FDA Issues Early Alert for Resmed Astral Ventilators
Resmed VentilatorPatients should continue using devices unless instructed otherwise by their healthcare provider The U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding a potentially high-risk issue affecting certain Resmed Astral 100 and...
One Contaminated Alcohol Pad, Multiple Recalls
A Lesson in Medical Device Supply Chain Quality At first glance, Cardinal Health's recent recall of Webcol™ Alcohol Prep Pads appears straightforward. A commonly used healthcare product was found to be contaminated with Paenibacillus phoenicis, creating a potential...
FDA Closes Moringa Salmonella Outbreak Investigation
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention have concluded their investigation into a multistate Salmonella Typhimurium outbreak linked to MOGO-brand moringa powder capsules distributed by MOGO Moringa LLC of St. Louis,...
Why the Sudden Focus on Testosterone?
New Military Screening Program Raises Questions About Science, Strategy and TransparencyThe Trump administration's decision to begin annual testosterone screening for active-duty and reserve service members age 30 and older has generated headlines and a growing number...
Arrow Corrects Kits With Recalled Injectable Medications
FDA Classifies Field Correction As Class I Recall Due to Risk of Serious Injury The U.S. Food and Drug Administration (FDA) has classified a correction issued by Arrow International, a subsidiary of Teleflex, as a Class I recall after certain convenience kits were...
FDA Approves First Oral PCSK9 Inhibitor for High Cholesterol
FDA Approves Lipfendra, the First Oral PCSK9 Inhibitor for High CholesterolLipfendra offers patients a once-daily pill alternative to injectable PCSK9 therapies The U.S. Food and Drug Administration (FDA) has approved Lipfendra (enlicitide), the first oral medication...
FDA Warning Letter Cites Illegal Drug Residue Levels in Dairy Cow
Letter Highlights FDA's Role in Protecting the Food Supply from Excessive Drug Residues When most people think about food safety inspections at slaughterhouses, they think of the U.S. Department of Agriculture. Few realize that the U.S. Food and Drug Administration...
FDA Warning Letter Targets Unapproved Fish and Bird Antibiotics
Letter Cites Unapproved Animal Drugs, Misbranding, and Antimicrobial Stewardship Concerns The U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) has issued a Warning Letter to The Fish Aid, an online distributor of antibiotics marketed for...
FDA Approves First Veterinary Amlodipine for Feline Hypertension
The U.S. Food and Drug Administration has approved Amodip (amlodipine besylate) chewable tablets for the control of systemic hypertension in cats. This approval marks a regulatory milestone as the first FDA-approved amlodipine product for veterinary use and the second...
Revival Animal Health Recalls Canine Milk Replacers
Revival Animal Health Recalls Canine Milk Replacers Due to Variable Vitamin D Levels Revival Animal Health, LLC of Orange City, Iowa, has voluntarily recalled multiple lots of its Breeder’s Edge® Foster Care® Canine Milk Replacer and Shelter’s Choice® Canine Milk...
Editorial: Two Days Later, Another Moringa Recall
Recurring Moringa Recalls Highlight Ongoing Supply Chain Concerns On July 17, the U.S. Food and Drug Administration officially closed its investigation into a multistate Salmonella outbreak linked to MOGO-brand moringa capsules. The outbreak was not insignificant....
Moringa Capsules Recalled for Potential Salmonella Contamination
Zen Principle Recalls Moringa Capsules After FDA Detects Salmonella in Raw Ingredient Relay Peak Research LLC, doing business as Zen Principle Naturals, has voluntarily recalled one lot of its Zen Principle® Moringa Capsules after learning that the raw moringa leaf...
FDA Closes Moringa Salmonella Outbreak Investigation
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention have concluded their investigation into a multistate Salmonella Typhimurium outbreak linked to MOGO-brand moringa powder capsules distributed by MOGO Moringa LLC of St. Louis,...
Kian Pee Wan Capsules Recalled for Undeclared Drug Ingredients
Kian Pee Wan Capsules Recalled Due to Undeclared Drug Ingredients Aphreseller (Buy-herbal.com), an online seller based in Flushing, New York, has voluntarily recalled all lots of Kian Pee Wan capsules after testing identified the presence of undeclared drug...
Eight Months of Moringa Salmonella Outbreaks
Recurring Salmonella Outbreaks Raise Questions About Supplement Oversight Since November 2025, the U.S. Food and Drug Administration has investigated and coordinated multiple recalls involving moringa dietary supplements contaminated with Salmonella. What initially...
FDA Closes Moringa Salmonella Outbreak Investigation
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention have concluded their investigation into a multistate Salmonella Typhimurium outbreak linked to MOGO-brand moringa powder capsules distributed by MOGO Moringa LLC of St. Louis,...
Arrow Corrects Kits With Recalled Injectable Medications
FDA Classifies Field Correction As Class I Recall Due to Risk of Serious Injury The U.S. Food and Drug Administration (FDA) has classified a correction issued by Arrow International, a subsidiary of Teleflex, as a Class I recall after certain convenience kits were...
FDA Approves First Oral PCSK9 Inhibitor for High Cholesterol
FDA Approves Lipfendra, the First Oral PCSK9 Inhibitor for High CholesterolLipfendra offers patients a once-daily pill alternative to injectable PCSK9 therapies The U.S. Food and Drug Administration (FDA) has approved Lipfendra (enlicitide), the first oral medication...
Alabama Center for Reproductive Medicine
Alabama Center for Reproductive Medicine, Birmingham, AL, 9/15/25, 3015364206
Editorial: Two Days Later, Another Moringa Recall
Recurring Moringa Recalls Highlight Ongoing Supply Chain Concerns On July 17, the U.S. Food and Drug Administration...
Moringa Capsules Recalled for Potential Salmonella Contamination
Zen Principle Recalls Moringa Capsules After FDA Detects Salmonella in Raw Ingredient Relay Peak Research LLC, doing...
Eight Months of Moringa Salmonella Outbreaks
Recurring Salmonella Outbreaks Raise Questions About Supplement Oversight Since November 2025, the U.S. Food and Drug...
Sincerus Florida, LLC dba SKNV. Pompano Beach, FL. 483 issued 5/29/2026
Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 5/29/2026 Short Title (70 char)...
Annovex Pharma Inc. Lorton, VA. 483 issued 6/03/2026
Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 6/03/2026 Short Title (70 char)...
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