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.  Device Use Haimen Shengbang Laboratory Equipment Co. Ltd.’s Viral Transport Media Container is a sampling swab and a tube containing viral sampling medium (the liquid that maintains a specimen

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 Palindrome and Mahurkar catheters are implanted and used in hemodialysis (treatment to filter waste and water from your blood), apheresis (a technology that separates donated blood components to

Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens which are packaged in cartons of five pens to the consumer level. This product is not the branded Semglee® pen but the unbranded Insulin Glargine-yfgn pens. This batch is being recalled

The U.S. Food and Drug Administration revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir), to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid. Read More

The U.S. Food and Drug Administration (FDA) is evaluating the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) with the following hemodialysis machines manufactured by Fresenius Medical Care: the 2008T, 2008K2, and 2008K models. The 2008K2 and 2008K models are no longer manufactured but may still be

Baxter Healthcare is recalling SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) due to the risk of not alarming for repeated upstream occlusion events. After an upstream occlusion alarm, failure to fully resolve any upstream occlusion before restarting the infusion can

Fresenius Kabi USA is voluntarily recalling seven lots of Sodium Acetate Injection, USP, 400 mEq/100 mL (4 mEq/mL), 100 mL fill in a 100 mL vial to the user level due to the presence of particulate matter found in reserve and/or stability sample vials. Microscopic and elemental analyses determined the presence of particulates composed of

The U.S. Food and Drug Administration (FDA) is warning people not to use the E25Bio COVID-19 Direct Antigen Rapid Test. This test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States, and it may include false labeling representing that the test is authorized by the FDA.

Buena, NJ, Teligent Pharma, Inc. is voluntarily recalling five lots of Lidocaine HCl Topical Solution 4% because the firm's testing has found it to be super potent based on an Out of Specification (OOS) result obtained at the 18-month stability timepoint. Use of the super potent product would result in a higher than intended lidocaine