Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home Tests: FDA Safety Communication

Date Issued: May 4, 2023 The U.S. Food and Drug Administration (FDA) is warning consumers and health care providers to stop using and throw out certain lots of recalled SD Biosensor, Inc. Pilot COVID-19 At-Home Tests, distributed by Roche Diagnostics. The FDA has significant concerns of bacterial contamination in the Pilot COVID-19 At-Home Test liquid…

Family Dollar is Initiating a Voluntary Recall of Certain Over-the-Counter Drug Products Because the Products Have Been Stored Outside of Labeled Temperature Requirements

Summary Company Announcement Date: May 04, 2023 FDA Publish Date: May 04, 2023 Product Type: Drugs Over-the-Counter Drugs Reason for Announcement: Recall Reason Description Product was stored outside of labeled temperature requirements. Company Name: Family Dollar Brand Name: Brand Name(s) Product Description: Product Description Over-The-Counter Drugs Company Announcement Family Dollar is initiating a voluntary retail…

Recall Notice – SD Biosensor, Inc. Requests Discontinuation of Use and Disposal of Specific Pilot™ COVID-19 At-Home Tests in the United States Due to Microbial Contamination in the Liquid Buffer Solution

Summary Company Announcement Date: May 04, 2023 FDA Publish Date: May 05, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Due to microbial contamination in the liquid buffer solution. Company Name: SD Biosensor, Inc. Brand Name: Brand Name(s) Product Description: Product Description COVID-19 At-Home Test Company Announcement SEOUL, South Korea, May 4,…

FDA D.I.S.C.O. Burst Edition: FDA approval of Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) for locally advanced or metastatic urothelial 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 a recent FDA cancer drug approval. On April 3, 2023, the FDA granted accelerated approval to…

Gear Isle Issues Voluntary Nationwide Recall of Pro Power Knight Plus, NUX Male Enhancement and DYNAMITE SUPER Capsules Due to the Presence of Sildenafil and Tadalafil

Summary Company Announcement Date: April 26, 2023 FDA Publish Date: April 26, 2023 Product Type: Drugs Over-the-Counter Drugs Reason for Announcement: Recall Reason Description Product contains undeclared tadalafil and sildenafil Company Name: Gadget Island, Inc. Brand Name: Brand Name(s) Pro Power Knight Plus, NUX, Dynamite Super Product Description: Product Description Male enhancement capsules Company Announcement…

Teva Initiates Voluntary Nationwide Recall of Specific Lots of FENTANYL Buccal Tablets CII Due to a Labeling Error

Summary Company Announcement Date: April 27, 2023 FDA Publish Date: April 28, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Safety updates were omitted in the Product Insert/Medication Guide (MG) Company Name: Teva Pharmaceuticals USA Brand Name: Brand Name(s) Mayne Pharma Inc. Product Description: Product Description FENTANYL Buccal Tablets CII Company Announcement 27…

Illumina Cybersecurity Vulnerability Affecting the Universal Copy Service Software May Present Risks for Patient Results and Customer Networks: Letter to Health Care Providers

April 27, 2023 The U.S. Food and Drug Administration (FDA) is informing health care providers and laboratory personnel about a cybersecurity vulnerability affecting the Universal Copy Service (UCS) software in the Illumina MiSeqDx, NextSeq 550Dx, iScan, iSeq 100, MiniSeq, MiSeq, NextSeq 500, NextSeq 550, NextSeq 1000/2000, and NovaSeq 6000 sequencing instruments. These instruments are medical…