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 have a quick update on another recent FDA cancer drug approval. On June 30, 2021, the FDA approved asparaginase erwinia chrysanthemi…
Philips Respironics CPAP, BiPAP, and Ventilator Recalls: Frequently Asked Questions
In June 2021, Philips Respironics voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP), and continuous positive airway pressure (CPAP) machines due to potential health risks. The polyester-based polyurethane foam used in these medical devices to lessen sound and vibration can break down. If this occurs, black pieces…
FDA D.I.S.C.O. Burst Edition: FDA approvals of Brukinsa (zanubrutinib), for adult patients with relapsed or refractory marginal zone lymphoma, and Exkivity (mobocertinib) for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations
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 two recent FDA cancer drug approvals. On September 14, 2021, the FDA granted accelerated approval to…
Esupplementsales, LLC Issues a Nationwide Recall All Lots of Hard Dawn Due to the Presence of Undeclared Tadalafil
Summary Company Announcement Date: January 28, 2022 FDA Publish Date: January 31, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Tadalafil Company Name: Esupplementsales, LLC Brand Name: Brand Name(s) Product Description: Product Description Hard Dawn Rise and Shine capsules Company Announcement FOR IMMEDIATE RELEASE – 01/28/2022 – Orangevale, CA, Esupplementsales, LLC is…
AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Polymyxin B for Injection USP, 500,000 Unit per Vial, Due to the Presence of Particulate Matter
Summary Company Announcement Date: January 26, 2022 FDA Publish Date: January 28, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Particulate Matter Company Name: AuroMedics Pharma LLC Brand Name: Brand Name(s) Auromedics Product Description: Product Description Polymyxin B for Injection USP, 500,000 Units/Vial Company Announcement FOR IMMEDIATE RELEASE – January 26,…
Stop Using Empowered Diagnostics COVID-19 Tests: FDA Safety Communication
Date Issued: January 28, 2022 The U.S. Food and Drug Administration (FDA) is warning people to stop using the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. These tests were distributed with labeling indicating they are authorized by the FDA, but neither test has been authorized, cleared, or approved…
Empowered Diagnostics Recalls COVID-19 Tests due to Risk of False Results
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious adverse health consequences or death. Recalled Product Empowered Diagnostics, LLC CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test All lot codes Distribution Dates: January 1, 2021 to November…
Don’t be Misled by “Latex Free” Claims
Natural rubber latex is used in the manufacture of various FDA-regulated products, such as condoms and medical gloves. Here, a physical science technician inspects medical gloves in related integrity testing at an FDA laboratory in Irvine, CA. For this and other FDA photos, go to Flickr. Español If you’re allergic to natural rubber latex, FDA…
Indoor Tanning: The Risks of Ultraviolet Rays
[embedded content] Español Sunlamps and tanning beds promise consumers a bronzed body year-round, but the ultraviolet (UV) radiation from these devices poses serious health risks. “Although some people think that a tan gives them a ‘healthy’ glow, any tan is a sign of skin damage,” says Sharon Miller, M.S.E.E., a Food and Drug Administration (FDA)…
Blaine Labs Issues Voluntary Nationwide Recall of RevitaDerm Wound Care Gel Due to Bacterial Contamination
Summary Company Announcement Date: January 27, 2022 FDA Publish Date: January 27, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description May be contaminated with Bacillus cereus Company Name: Blaine Labs Company Brand Name: Brand Name(s) RevitaDerm Product Description: Product Description Wound Care Gel Company Announcement SANTA FE SPRINGS, Calif., Jan. 27, 2022 —…