99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000128741 10193489069587 30193489069581 99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000134505 10193489069587 30193489069581 99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000133893 10193489069587 30193489069581 99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000135769 10193489069587 30193489069581 99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000139596 10193489069587 30193489069581…
Early Alert: Solution Set Issue from Baxter Healthcare Corporation
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Baxter Healthcare Corporation has…
FDA D.I.S.C.O. Burst Edition: FDA approval of Bizengri (zenocutuzumab-zbco) for Treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval. On December 4, 2024, the FDA granted accelerated approval to…
Early Alert: Extracorporeal Blood Circuit Issue from Nuwellis
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Nuwellis has issued a…
Early Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Olympus has issued a…
Astellas Pharma US, Inc. Issues Voluntary Nationwide Recall of One Lot of PROGRAF® 0.5mg (Tacrolimus) and One Lot of ASTAGRAF XL® 0.5mg (Tacrolimus Extended-Release Capsules) Because Bottles Shipped to U.S. May Contain Empty Capsules
Summary Company Announcement Date: December 23, 2024 FDA Publish Date: December 24, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Bottles may contain empty capsules. Company Name: Astellas Pharma US, Inc. Brand Name: Brand Name(s) Product Description: Product Description Tacrolimus and Tacrolimus Extended-Release capsules Company Announcement FOR IMMEDIATE RELEASE – NORTHBROOK, IL, Dec….
Alcon Laboratories Issues Voluntary Nationwide Recall of One (1) Lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101), Due to Fungal Contamination
Summary Company Announcement Date: December 21, 2024 FDA Publish Date: December 23, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Fungal Contamination Company Name: Alcon Laboratories Brand Name: Brand Name(s) Product Description: Product Description Lubricant Eye Drugs Company Announcement FOR IMMEDIATE RELEASE – 12/21/2024 – Fort Worth, Texas. Alcon Laboratories is…
Catheter Correction: Boston Scientific Updates Use Instructions for POLARx and POLARx FIT Cryoablation Balloon Catheters due to Higher than Anticipated Number of Reports of Atrio-Esophageal Fistula
This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions. Affected Product Product Names:…
Early Alert: Nephroscope Sheath Issue from Trokamed GmbH
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Trokamed has issued a…
Endo USA, Inc. Issues Voluntary, Nationwide Recall of Adrenalin® Chloride Solution (EPINEPHrine Nasal Solution, USP) Due to the Potential for Administration Errors
Summary Company Announcement Date: December 20, 2024 FDA Publish Date: December 20, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Product is an unapproved drug. Company Name: Endo, Inc. Brand Name: Brand Name(s) Par Pharmaceutical Product Description: Product Description Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP) Company Announcement MALVERN, PA, December 20, 2024…