FDA Recalls and Safety Announcements

Angie Szumlinski Announcements

Boston Scientific Recalls INGENIO Family of Pacemakers and CRT-Ps Due to Risk of Transition to Safety Mode SterRx, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL Due to Microbial Contamination Stop Using Lepu Medical Technology SARS-CoV-2 Antigen and Leccurate Antibody Tests: FDA Safety Communication

Several LeadCare Blood Lead Tests Recalled

Angie Szumlinski Announcements

On July 1, 2021, the U.S. Food and Drug Administration (FDA) issued a notice that Magellan Diagnostics, Inc., is recalling its LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests due to a significant risk of falsely low results. FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious …

Monoclonal Antibody Therapy Paused

Angie Szumlinski Announcements, News

“As of June 25, 2021, the CDC has identified that the combined frequencies of the SARS-CoV-2 P.1/Gamma variant (first identified in Brazil) and the B.1.351/Beta variant (first identified in South Africa) throughout the United States now exceed 11% and are trending upward. Results from in vitro assays that are used to assess the susceptibility of viral variants to particular monoclonal …

Varenicline (Chantix) Recall

Angie Szumlinski Announcements

On July 2, 2021, the U.S. Food and Drug Administration (FDA) issued an alert notifying patients and health care professionals to Pfizer’s voluntary recall of Varenicline, also known as Chantix. According to the alert, “the company is recalling varenicline because it may contain levels of a nitrosamine impurity, called N-nitroso-varenicline, above FDA’s acceptable intake limit. N-nitroso-varenicline may be associated with …

Longer Refrigerator Storage – Pfizer-BioNTech Vaccine – FDA

Angie Szumlinski Featured

The following brief was issued by the FDA on May, 19, 2021: Making COVID-19 vaccines widely available is key to getting people vaccinated and bringing the pandemic to an end. Pfizer Inc. submitted data to the FDA to support storage of undiluted, thawed vials of its COVID-19 vaccine for up to one month at refrigerator temperatures. This change should make …

FDA – Instructions – Self-Collection

Angie Szumlinski Featured

The following article was published as a letter to Health Care Providers from the FDA on October 7, 2020. The FDA recommends health care providers provide visual (written or video) step-by-step instructions, in addition to verbal instructions, to patients who, in a health care setting, are self-collecting anterior nares (nasal) samples for SARS-CoV-2 testing. Written instructions may be provided on …

FDA – CoV-2 Antibody Test and Immunity

Angie Szumlinski Health

“The FDA is reminding the public of the limitations of COVID-19 antibody, or serology, testing and providing additional recommendations about the use of antibody tests in people who received a COVID-19 vaccination.“ Antibody tests can play an important role in identifying individuals who may have been exposed to the SARS-CoV-2 virus and may have developed an adaptive immune response. However, …

FDA Grants Accelerated Approval for Alzheimer’s Drug

Angie Szumlinski Announcements, News

On June 7, 2021 the FDA approved a new treatment for Alzheimer’s – Aduhelm (aducanumab). The approval was granted through the “accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments”. The director of the FDA’s Center for Drug Evaluation and Research, Patrizia Cavazzoni, M.D., …


FDA News Release: COVID-19 Update

Angie Szumlinski News

On May 18th, 2021, the FDA announced new actions they were taking in their continued response to the COVID-19 pandemic. Please read their update below, and visit their website for more information: – On May 17, the FDA provided summary information about the status of CytoDyn, Inc.’s development program for the monoclonal antibody investigational drug, leronlimab, for the treatment of COVID-19. The …