Image Español The bad news: Heartworm disease can be fatal to dogs, cats, and ferrets. The good news: You can protect your pet from this disease. An ounce of prevention is worth a pound of cure Heartworms can infect your pet year-round and preventing them is much easier, and healthier, for your pet than getting heartworms…
Ingesting or Inhaling Nitrite “Poppers” Can Cause Severe Injury or Death
Image Español Health care providers are reporting increases in deaths and hospitalizations related to intentional ingestion or inhalation of nitrite products for recreational use, including sexual experience enhancement. Commonly referred to as “poppers,” these products contain chemical substances similar to the prescription medication, amyl nitrite, which is prescribed for the relief of chest pain. However,…
Philips Respironics Recalls Certain Reworked Philips Respironics Trilogy 100/200 and Garbin Ventilators Due to Potential for Silicone Foam Adhesion Failure and Residual PE‐PUR Foam Debris
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: Philips Respironics Trilogy 100, Trilogy 200, and Garbin Plus ventilators Product Models and Serial Numbers: See recall database entries Distribution Dates: March 1, 2022, to…
FDA D.I.S.C.O. Burst Edition: FDA approvals of Tukysa (tucatinib) with trastuzumab for colorectal cancer and Brukinsa (zanubrutinib) for chronic lymphocytic leukemia or small lymphocytic 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 two recent FDA cancer drug approvals. On January 19, 2023, the FDA granted accelerated approval to…
Medicines for Your Pet: What’s The Difference Between FDA-approved & Pharmacy-compounded Drugs?
Image Español If you’ve ever had to give your cat a dose of medicine, you know that it can go sideways quickly. While no cat enjoys the process, some might be more cooperative depending on how the drug is given. For example, some cats tolerate taking pills easier than liquid, while others make the pill-giving…
GE HealthCare Recalls Nuclear Medicine 600/800 Series Systems for Risk of Detector Fall That May Injure 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 Name: Nuclear Medicine 600/800 Series systems Product Models: Brivo 615 Discovery NM 630 Optima 640 Discovery NM/CT: 670 DR, 670 ES, 670 Pro, 670 CZT NM:…
Actualizado: Problemas de mamografía en Advanced Women Imaging en Guttenberg, NJ
English Actualización – 7 de febrero de 2023: El certificado de la Ley de estándares de calidad de mamografía (MQSA, por sus siglas en inglés) para Advanced Women Imaging (en inglés), en 6414 Bergenline Avenue, West New York, NJ (Bergenline) fue revocado hasta el 4 de enero de 2025. Actualmente, el centro no está acreditado…
Volt Candy Issues Voluntary Nationwide Recall of PrimeZen Black 6000 Capsules Due to Presence of Sildenafil and Tadalafil
Summary Company Announcement Date: February 13, 2023 FDA Publish Date: February 13, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains undeclared tadalafil and sildenafil Company Name: Volt Candy Brand Name: Brand Name(s) Product Description: Product Description PrimeZEN Black 6000 male enhancement capsules Company Announcement FOR IMMEDIATE RELEASE – 2/13/2023 – Pomona,…
Universal Meditech Inc. Issues Nationwide Recall of Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit
Summary Company Announcement Date: February 09, 2023 FDA Publish Date: February 10, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Products were distributed without appropriate premarket clearance or approval which potentially could result in inaccurate test results due to lack of performance evaluation by the FDA. Company Name: Universal Meditech Inc. Brand…
Universal Meditech Inc. Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA
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. The devices described in this recall notice are the same devices announced in the FDA safety communication Do Not Use Skippack Medical Lab SARS-CoV-2 COVID-19 Tests. Recalled Product Product Names:…