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Update on the Safety of Andexxa by AstraZeneca: FDA Safety Communication

Murilo Freitas - 05:00, 18 de December de 2025135
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

http://www.fda.gov/safety/medical-product-safety-information/update-safety-andexxa-astrazeneca-fda-safety-communication

 
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Olympus Announces Voluntary Corrective Action for the Single-Use Ligating Device

Murilo Freitas - 05:00, 17 de December de 202583
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.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olympus-announces-voluntary-corrective-action-single-use-ligating-device

 
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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

Murilo Freitas - 05:00, 15 de December de 2025258
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,

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/medinatura-new-mexico-inc-expands-voluntary-nationwide-recall-reboost-nasal-spray-and-include

 
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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

Murilo Freitas - 05:00, 15 de December de 2025767
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

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/stuffbynainax-llc-issues-voluntary-nationwide-recall-mr7-super-700000-dietary-supplement-due

 
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