Pfizer is voluntarily recalling five (5) lots of Accupril (Quinapril HCl) tablets distributed by Pfizer to the patient (consumer/user) level due to the presence of a nitrosamine, Nnitroso-quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level.
Listing of Medical Device 2022 Safety Communications
Pregnant patients should discuss test results with a health care provider before making any decisions about their pregnancy
Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its Insulin Glargine (Insulin glargineyfgn) Injection, 100 units/mL (U-100), which is packaged in a 10 mL vial that is inside a carton. This product is not the branded Semglee vial but the unbranded Insulin Glargine
The U.S. Food and Drug Administration (FDA) wants to increase awareness about the intended use of imaging software for intracranial large vessel occlusion or LVO.
FDA is sharing recommendations and updates to help improve duodenoscope reprocessing.
The FDA is providing recommendations for certain high-risk populations may be more vulnerable to potential adverse health effects of mercury exposure from dental amalgam.
Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication
The FDA wants to raise awareness among health care providers about the risk of infections associated with reprocessed urological endoscopes.
Do not use high-level disinfection methods for reprocessing affected urological endoscopes from Karl Storz.
Best Brands Consumer Products, Inc. is voluntarily recalling two (2) finished product lots of The Mandalorian Hand Sanitizer Ethyl Alcohol 68%, available in green and blue formulations and Mickey Mouse Hand Sanitizer Ethyl Alcohol 68% blue formulation to the consumer level.
Chatsworth, California, F&S Medical Supply, dba Pink Toyz is voluntarily recalling one lot of Pink Pussycat 3000 mg capsules to the consumer level. FDA analysis has found the product Pink Pussycat to be tainted with sildenafil, an ingredient known as a phosphodiesterase (PDE-5) inhibitor found in an
The LeadCare tests are used to detect blood lead level but has risk of falsely low results.
The FDA is recommending that newborns and children through 3 years old have follow-up thyroid monitoring within 3 weeks after receiving injections of contrast media containing iodine, also called “contrast dye,” for X-rays and other medical imaging procedures.
Unilever United States is voluntarily recalling two Suave 24-Hour Protection Aerosol Antiperspirants to the consumer level. An internal review showed slightly elevated levels of benzene in some product samples. While benzene is not an ingredient in any of the recalled products, the review showed tha
Teva Pharmaceuticals has initiated a voluntary nationwide recall of lot 31329657B of IDArubicin Hydrochloride Injection USP 5 mg/5 mL vial, to the user level in the United States. This voluntary recall is initiated based on an internal inspection that found particulate matter in one vial of the prod
Lawrence, KS, Plastikon Healthcare, LLC is voluntarily recalling three (3) lots of Milk of Magnesia 2400 mg/30 mL Oral Suspension, one (1) lot of Acetaminophen 650mg/ 20.3mL, and six (6) lots of Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL to the hospital, clinic
List of Medical Device recalls in 2022.
): Certain Point of Care Celltrion USA’s DiaTrust COVID-19 Ag Rapid Tests are being recalled because they were labeled for Research Use Only but distributed to customers for non-research, unauthorized uses are being recalled.
Pfizer is voluntarily recalling Accuretic (quinapril HCl/hydrochlorothiazide) tablets distributed by Pfizer as well as two authorized generics distributed by Greenstone (quinapril and hydrochlorothiazide and quinapril HCl/ hydrochlorothiazide) to the patient(consumer/user) level due to the presence