The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Oxylog 3000 Plus Emergency and Transport Ventilator Part Numbers: 5704811 and 5704813 Product Material Numbers: See Recall Database Entry Distribution Dates: April 30, 2012 to…
Megadyne Recalls MEGA 2000 and MEGA Soft Reusable Patient Return Electrodes for Risk of Serious Burn Injuries to Patients
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names and Codes: Devices Recalled in the U.S.: 21,200 Dates Distributed: March 11, 2021 – May 9, 2023 Date Initiated by Firm: June 1, 2023 Device…
UPDATE: Paclitaxel-Coated Devices to Treat Peripheral Arterial Disease Unlikely to Increase Risk of Mortality – Letter to Health Care Providers
July 11, 2023 The U.S. Food and Drug Administration (FDA) is informing health care providers about updated information associated with paclitaxel-coated devices used to treat peripheral arterial disease (PAD). Based on the FDA’s review of the totality of the available data and analyses, we have determined that the data does not support an excess mortality…
Cipla Issues Voluntary Nationwide Recall of Six Batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) Due to Container Defect
Summary Company Announcement Date: July 06, 2023 FDA Publish Date: July 07, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Failure to deliver the recommended dose Company Name: Cipla Brand Name: Brand Name(s) Product Description: Product Description Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) Company Announcement FOR IMMEDIATE RELEASE – Mumbai,…
How to Report Problems with E-Cigarettes, Cigarettes, Cigars, or Other Tobacco Products to the FDA
[embedded content] Español How can I report problems with tobacco products? The Safety Reporting Portal (SRP) allows you to tell the U.S. Food and Drug Administration’s Center for Tobacco Products about health, quality, or safety issues with tobacco products, including products containing nicotine from any source. Reports about unexpected tobacco-related health or product problems can…
UPDATE: NuVasive Specialized Orthopedics’ Precice Devices – Letter to Health Care Providers
June 28, 2023 The U.S. Food and Drug Administration (FDA) is providing an update to information and recommendations for the NuVasive Specialized Orthopedics’ (NuVasive) Precice Intra-medullary Limb Lengthening (IMLL) system, which includes Precice Short. In March 2023, NuVasive received FDA 510(k) clearance for the expanded use of the Precice IMLL system (including Precice Short) for…
Teleflex, and Arrow International, Recall ARROW Endurance Extended Dwell Peripheral Catheter System for Risk of Catheter Separation and Leakage
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: ARROW Endurance Extended Dwell Peripheral Catheter System Product Codes: See Recall Database Entry Devices Recalled in the U.S.: 262,016 Dates Distributed: October 26, 2018 to…
FDA D.I.S.C.O. Burst Edition: FDA approval of Epkinly (epcoritamab-bysp) for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma
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 May 19, 2023, the FDA granted accelerated approval to…
How to Properly Store E-Liquids and Prevent Accidental Exposure of E-Liquids to Children
Español As e-cigarettes (also called “vapes”) have become more popular, more children are being accidentally exposed to nicotine-containing e-liquids—which can cause injury and even death. If you’re an adult who vapes, the U.S. Food and Drug Administration wants you to know that it’s important to keep these products away from kids, and to be prepared…
The Harvard Drug Group, LLC Issues Voluntary Nationwide Recall of Dronabinol Capsules, USP, 2.5 mg and Ziprasidone Hydrochloride Capsules, 20 mg Due to Label Mix-up
Summary Company Announcement Date: June 13, 2023 FDA Publish Date: June 14, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Packaging may contain incorrect product due to labeling mix-up Company Name: The Harvard Drug Group, LLC d/b/a Major Pharmaceutical and Rugby Laboratories Brand Name: Brand Name(s) Major Pharmaceuticals Product Description: Product Description Dronabinol…