Image 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 process…
Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), Due to the Potential for a Missing Label in the Batch
Summary Company Announcement Date: April 12, 2022 FDA Publish Date: April 12, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Label may be missing on some vials Company Name: Mylan Pharmaceuticals, Inc. a Viatris Company Brand Name: Brand Name(s) Product Description: Product Description Insulin Glargine (Insulin glargine-yfgn) Injection Company Announcement FOR IMMEDIATE RELEASE…
Intended Use of Imaging Software for Intracranial Large Vessel Occlusion – Letter to Health Care Providers
April 11, 2022 The U.S. Food and Drug Administration (FDA) is reminding health care providers about the intended use of radiological computer-aided triage and notification (CADt) devices for intracranial large vessel occlusion (LVO). LVO is an obstruction of one of the large arteries in the brain and is a common cause of acute ischemic strokes….
FDA D.I.S.C.O. Burst Edition: FDA approvals of Opdualag (nivolumab and relatlimab-rmbw) for unresectable or metastatic melanoma, and Keytruda (pembrolizumab) for patients with advanced endometrial carcinoma
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 March 18, 2022, the FDA approved nivolumab and relatlimab-rmbw…
Pfizer Voluntary Nationwide Recall of Lots of Accuretic (Quinapril HCl/Hydrochlorothiazide), Quinapril and Hydrochlorothiazide Tablets, and Quinapril HCl/Hydrochlorothiazide Tablets Due to N-Nitroso-Quinapril Content
Summary Company Announcement Date: March 22, 2022 FDA Publish Date: March 22, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of a nitrosamine, N-nitroso-quinapril Company Name: Pfizer Brand Name: Brand Name(s) Accuretic, Greenstone Brand Product Description: Product Description Accuretic™ (quinapril HCl/hydrochlorothiazide); quinapril and hydrochlorothiazide; and quinapril HCl/hydrochlorothiazide tablets Company Announcement NEW YORK,…
Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication
Date Issued: April 5, 2022 The U.S. Food and Drug Administration (FDA) is updating the April 2020 Safety Communication to provide new information supporting the transition to fully disposable duodenoscopes and those with disposable components as well as new information on completed postmarket surveillance studies (also known as 522 studies). Given the cleaning concerns and…
UPDATE: Change in Reprocessing Methods with Certain Karl Storz Urological Endoscopes – Letter to Health Care Providers
April 4, 2022 As the U.S. Food and Drug Administration (FDA) continues to evaluate the risk of patient infections and contamination issues associated with reprocessed urological endoscopes, the FDA is aware that the current reprocessing instructions for certain urological endoscopes manufactured by Karl Storz are inadequate and are being changed updated by Karl Storz. The…
Best Brand Consumers Products, Inc. Issues Voluntary Recall of Mickey Mouse Hand Sanitizer Ethyl Alcohol 68% Due to Presence of Methanol and the Mandalorian Hand Sanitizer Ethyl Alcohol 68% Due to the Presence of Benzene
Summary Company Announcement Date: April 01, 2022 FDA Publish Date: April 01, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Methanol in Mickey Mouse and Presence of Benzene in The Mandalorian Company Name: Best Brands Consumer Products, Inc. Brand Name: Brand Name(s) Mickey Mouse, The Mandalorian Product Description: Product Description Hand…
F&S Medical Supply, DBA Pink Toyz Issues Voluntary Nationwide Recall of Pink Pussycat Capsules Due to the Presence of Undeclared Sildenafil
Summary Company Announcement Date: April 01, 2022 FDA Publish Date: April 01, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil Company Name: F&S Medical Supply, dba Pink Toyz Brand Name: Brand Name(s) F&S Medical Supply, dba Pink Toyz Product Description: Product Description Pink Pussycat Capsules Company Announcement FOR IMMEDIATE RELEASE –…
Unilever Issues Voluntary Nationwide Recall of Suave 24-Hour Protection Aerosol Antiperspirant Powder and Suave 24-Hour Protection Aerosol Antiperspirant Fresh Due to Presence of Slightly Elevated Levels of Benzene
Summary Company Announcement Date: March 30, 2022 FDA Publish Date: March 30, 2022 Product Type: CosmeticsDrugs Deodorant Reason for Announcement: Recall Reason Description Elevated levels of benzene Company Name: Unilever Brand Name: Brand Name(s) Product Description: Product Description Aerosol Antiperspirants Company Announcement March 30, 2022 – Englewood Cliffs, New Jersey– Unilever United States is voluntarily…