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 Alaris Infusion Pump Module Model 8100 Bezel, purchased and/or installed by Step-Har Medical Models: Alaris Model 8100 Serial Numbers: 12747983 and 9919591 Devices Recalled in the U.S.:…
Dash Xclusive Issues Voluntary Nationwide Recall of Imperia Elita Vitaccino Coffee Due to the Presence of Undeclared Sibutramine and Fluoxetine
Summary Company Announcement Date: May 27, 2021 FDA Publish Date: May 28, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Sibutramine and Fluoxetine Company Name: Dash Xclusive Brand Name: Brand Name(s) Imperia Elita Product Description: Product Description Imperia Elita Vitaccino Coffee Company Announcement Dash Xclusive is voluntarily recalling all lots of Imperia…
Lepu Medical Technology Recalls SARS-CoV-2 Antigen Rapid Test Kit and Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) due to Risk of False 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 Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) All lot codes Manufacturing Dates: Approximately March 20, 2020…
Update: FDA Recommends Transition from Use of Non-NIOSH-Approved and Decontaminated Disposable Respirators – Letter to Health Care Personnel and Facilities
May 27, 2021 The U.S. Food and Drug Administration (FDA) is recommending health care personnel and facilities transition away from crisis capacity conservation strategies, such as using non-NIOSH-approved disposable respirators, including non-NIOSH-approved imported respirators such as KN95s. This recommendation is in follow-up to the April 9, 2021, letter in which the FDA recommended a transition…
Help the FDA Prevent the Sale of Tobacco Products to Young People
Image Español Many teens underestimate how easy it is to become addicted to nicotine. This raises concerns because young people are at greatest risk of nicotine addiction because their brains are still developing. In fact, as little as one cigarette a month is all it takes for some teens to show symptoms of addiction. And…
Ocaliva (obeticholic acid) by Intercept Pharmaceuticals: Drug Safety Communication – Due to Risk of Serious Liver Injury, FDA Restricts Use of Ocaliva in Primary Biliary Cholangitis Patients with Advanced Cirrhosis
[Posted 05/26/2021] AUDIENCE: Patient, Health Professional, Pharmacy ISSUE: The FDA is restricting the use of the liver disease medicine Ocaliva (obeticholic acid) in patients having primary biliary cholangitis (PBC) with advanced cirrhosis of the liver because it can cause serious harm. Some PBC patients with cirrhosis who took Ocaliva, especially those with evidence of advanced cirrhosis, developed…
4 Medication Safety Tips for Older Adults
Image Whether you’re settling into your sixties or heading into your nineties, be careful when taking prescription and over-the-counter medicines, herbal preparations, and supplements. And if you’re caring for older loved ones, help them stay safe too. Why the special concern? The older you get, the more likely you are to use additional medicines, which…
Medically Minded Hand Sanitizer– Nationwide Recall Expansion Due to The Presence of Undeclared Methanol
Summary Company Announcement Date: May 20, 2021 FDA Publish Date: May 25, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of methanol Company Name: Global Sanitizers Brand Name: Brand Name(s) Medically Minded Product Description: Product Description Hand Sanitizer Company Announcement This is to inform you of a product recall involving: Medically Minded…
Watch Out for False Promises on Some Dietary Supplements
Image You may know someone who has been unable to get pregnant due to infertility issues. According to the Centers for Disease Control and Prevention, about 12 percent of women aged 15 to 44 in the United States have difficulty becoming pregnant or carrying a pregnancy to term. “Fertility” Products Prey on Vulnerability Marketers are…
Antibody Testing Is Not Currently Recommended to Assess Immunity After COVID-19 Vaccination: FDA Safety Communication
Date Issued: May 19, 2021 The U.S. Food and Drug Administration (FDA) is reminding the public and health care providers that results from currently authorized SARS-CoV-2 antibody tests should not be used to evaluate a person’s level of immunity or protection from COVID-19 at any time, and especially after the person received a COVID-19 vaccination….