Smiths Medical Issues Worldwide Notification Regarding the Recall of Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringe With Skewed Graduation Markings

Summary Company Announcement Date: June 16, 2021 FDA Publish Date: June 17, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Skewed odd number line graduation markings on syringe barrels. Company Name: Smiths Medical Brand Name: Brand Name(s) Product Description: Product Description Hypodermic Needle-Pro Fixed Needle Insulin Syringes Company Announcement Smiths Medical has…

How to Report Problems with Flea and Tick Products

Image Fleas and ticks can be more than just an itchy annoyance to your pets—they can cause serious harm. So it’s important to know how to use flea and tick products safely.  It’s also important to know whom to report to if you’re experiencing problems with these products. Flea and tick products for pets are…

FDA D.I.S.C.O. Burst Edition: FDA approvals of Lumakras (sotorasib) for patients with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer, and Truseltiq (infigratinib) for unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement

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 May 28, 2021, FDA granted accelerated approval to sotorasib…

Philips Issues a Recall Notification* to Mitigate Potential Health Risks Related to the Sound Abatement Foam Component in Certain Sleep and Respiratory Care Devices

Summary Company Announcement Date: June 14, 2021 FDA Publish Date: June 15, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices Company Name: Philips Brand Name: Brand Name(s) Product Description: Product Description Philips Bi-Level Positive Airway Pressure…

Older Therapies Aren’t Necessarily Better for Thyroid Hormone Replacement

Image Millions of people have thyroid glands that don’t make enough thyroid hormone to meet their body’s needs. Hypothyroidism, also called underactive thyroid, is the most common reason some people need thyroid hormone replacement. Hypothyroidism is treated by replacing the hormones that your own thyroid can no longer make. Thyroid hormone medicines mimic these hormones….

Viona Pharmaceuticals Inc., Issues Voluntary Nationwide Recall of Metformin HCl Extended-Release Tablets, USP 750 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

Summary Company Announcement Date: June 11, 2021 FDA Publish Date: June 11, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Contains Nitrosodimethylamine (NDMA) impurities Company Name: Viona Pharmaceuticals Inc. Brand Name: Brand Name(s) Viona Pharmaceuticals Inc. Product Description: Product Description Metformin Hydrochloride Extended-Release Tablets Company Announcement Viona Pharmaceuticals Inc., is voluntarily recalling 2…

Stop Using Innova SARS-CoV-2 Antigen Rapid Qualitative Test: FDA Safety Communication

Date Issued: June 10, 2021 The U.S. Food and Drug Administration (FDA) is warning the public to stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use. The FDA has significant concerns that the performance of the test has not been adequately established, presenting a risk to health. In addition, labeling distributed with…

Innova Medical Group Recalls Unauthorized SARS-CoV-2 Antigen Rapid Qualitative Test with Risk of False Test Results

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 Innova SARS-CoV-2 Antigen Rapid Qualitative Test (also distributed under the names Innova COVID-19 Self-Test Kit (3T Configuration), Innova SARS-CoV-2-Antigen Rapid Qualitative Test (7T Configuration), and Innova SARS-CoV-2-Antigen…