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Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume Pumps
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
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FDA Grants Two National Priority Vouchers
FDA Grants Two National Priority Vouchers
http://www.fda.gov/news-events/press-announcements/fda-grants-two-national-priority-vouchers
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FDA Explores New Contracting Approach to Advance Public Health Innovation
FDA Explores New Contracting Approach to Advance Public Health Innovation
http://www.fda.gov/news-events/press-announcements/fda-explores-new-contracting-approach-advance-public-health-innovation
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Update on the Safety of Andexxa by AstraZeneca: FDA Safety Communication
Since approval, the FDA has received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo). Based on available data, the serious risks including the increase in thromboembolic
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Olympus Announces Voluntary Corrective Action for the Single-Use Ligating Device
Center Valley, Pa., (December 5, 2025)-Olympus Corporation today announced a voluntary medical device corrective action for its Single-Use Ligating Device (“Polyloop”) following identification of a potential safety issue.
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MediNatura New Mexico, Inc. Expands Voluntary Nationwide Recall of ReBoost Nasal Spray and to include ClearLife Allergy Nasal Spray Due to Microbial Contamination
FOR IMMEDIATE RELEASE – December 16, 2025 – Albuquerque, New Mexico, MediNatura New Mexico, Inc. is voluntarily recalling all lots of ReBoost Nasal Spray to the consumer level. The product has been found to contain yeast/mold and microbial contamination with one species identified as Achromobacter,
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StuffbyNainax LLC Issues Voluntary Nationwide Recall of MR.7 SUPER 700000 Dietary Supplement Due to the Presence of Undeclared Sildenafil and Tadalafil
Huntsville, Texas — StuffbyNainax LLC is voluntarily recalling all lots of MR.7 SUPER 700000 capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil, which are active ingredients in FDA-approved prescription drugs used to treat male erectile dys
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FDA Takes Action to Improve Recall Effectiveness Following Infant Botulism Outbreak Investigation Linked to ByHeart Infant Formula
FDA Takes Action to Improve Recall Effectiveness Following Infant Botulism Outbreak Investigation Linked to ByHeart Infant Formula
http://www.fda.gov/news-events/press-announcements/fda-takes-action-improve-recall-effectiveness-following-infant-botulism-outbreak-investigation
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FDA Eliminates Major Barrier to Using Real-World Evidence in Drug and Device Application Reviews
FDA Eliminates Major Barrier to Using Real-World Evidence in Drug and Device Application Reviews
http://www.fda.gov/news-events/press-announcements/fda-eliminates-major-barrier-using-real-world-evidence-drug-and-device-application-reviews
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FDA Proactively Awards National Priority Voucher Based on Strong Phase 3 Study Results
FDA Proactively Awards National Priority Voucher Based on Strong Phase 3 Study Results
http://www.fda.gov/news-events/press-announcements/fda-proactively-awards-national-priority-voucher-based-strong-phase-3-study-results
