Pharma Reviews: September 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: September 30, 2022 

The FDA is continuing, under certain conditions, the flexibilities regarding importation and domestic production of certain infant formula products as part of its effort to provide stable, longer-term access to safe and nutritious infant formula across the country.
Read more: FDA Pathway Supports Long-Term Stability, Diversity of Safe and Nutritious Infant Formula Supply in the U.S.

The LifeSPARC System is being recalled for risk that users can inadvertently cause extended pump stop when replacing the controller after software malfunction.
Read more: LivaNova (TandemLife) Recalls LifeSPARC System for Risk of Unintentional Extended Pump Stop During Controller Critical Failure

Golden State Medical Supply, Incorporated (GSMS, Inc.) - Camarillo, CA has initiated a voluntary recall of the products listed in the table below because a report was received that a bottle containing Clopidogrel 75mg Tablets produced with lot# GS046745 was mislabeled as Atenolol 25mg Tablets. This
Read more: Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Atenolol 25 mg Tablets and Clopidogrel 75 mg Tablets Due to a Label Mix-up

The FDA approved Relyvrio (sodium phenylbutyrate/taurursodiol) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease.
Read more: FDA Approves New Treatment Option for Patients with ALS

Proper Trade LLC/My Stellar Lifestyle is voluntarily recalling Wonder Pill lot 20210912 and lot 31853-501
Read more: Proper Trade LLC/My Stellar Lifestyle Issues Voluntary Nationwide Recall of Wonder Pill Capsules Due to the Presence of Undeclared Tadalafil

FDA and the Veterans Health Administration (VHA) are announcing a collaboration intended to help accelerate American medical device innovation to further improve and benefit public health.
Read more: FDA, Veterans Health Administration Collaborate to Help Accelerate Medical Device Innovation and Advancement of Care

FDA Proposes Updated Definition of ‘Healthy’ Claim on Food Packages to Help Improve Diet, Reduce Chronic Disease
Read more: FDA Proposes Updated Definition of ‘Healthy’ Claim on Food Packages to Help Improve Diet, Reduce Chronic Disease

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: September 27, 2022

East Windsor, New Jersey, Eugia US LLC (formerly AuroMedics Pharma LLC) has initiated a voluntary recall of lot number AC22006 of AuroMedics Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), 10 mL single dose vial to the consumer level from the U.S. market due to a product complaint for the pr
Read more: Eugia US LLC Issues Voluntary Nationwide Recall of Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), Due to the Presence of Particulate Matter

The FDA updated its COVID-19 test policy to ensure continued access to tests while encouraging the transition of these important public health tools to traditional premarket review pathways.
Read more: Coronavirus (COVID-19) Update: FDA Updates COVID-19 Test Policy, Encourages Developers to Seek Traditional Premarket Review for Most Test Types

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: September 23, 2022

Certain Philips Respironics BiPAP machines are recalled due to a plastic issue that may expose patients to certain chemicals of concern.
Read more: Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern

The FDA issued draft guidance that, when finalized, will provide the agency’s perspective on the ethical considerations for including and protecting children in clinical trials and will assist industry, sponsors and IRBs when considering the enrollment of children.
Read more: New FDA Draft Guidance Aims to Protect Children who Participate in Clinical Trials

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: September 20, 2022

Today, the FDA released a review of review activities and decision-making related to the shutdown of Abbott’s Sturgis, Michigan, infant formula facility.
Read more: FDA Concludes Internal Review of Agency Actions Related to the U.S. Infant Formula Supply

Orlando, Florida. Salon Technologies International. Inc. is voluntarily recalling one lot of Antica Ocean Citron Hand Sanitizer (alcohol) Gel 65%, Lot 1166A. Expiration 6/18/2023 to the consumer level. Firm lab testing has found the product to contain benzene. Benzene is classified as a human carci

Read more: Salon Technologies, Inc. Issues Voluntary Nationwide Recall of Antica Ocean Citron Hand Sanitizer ( Alcohol ) Gel 65% Due to the Presence of Benzene

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: September 16, 2022

Family Dollar is initiating a voluntary retail level product recall of certain products regulated by the U.S. Food and Drug Administration (FDA) that were stored and inadvertently shipped to certain stores on or around May 1, 2022 through June 10, 2022 due to product being stored outside of labeled
Read more: Voluntary Recall of Certain Over-the-Counter Products Sold at Family Dollar Stores Because They Were Stored Outside of Temperature Requirements

Family Dollar is initiating a voluntary retail level product recall of certain products regulated by the U.S. Food and Drug Administration (FDA) that were stored and shipped to a limited number of stores in AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, and UT on or around May 1, 2022 through June 21, 202
Read more: Voluntary Recall of Certain Colgate Products Sold at Family Dollar Stores Because They Were Stored Outside of Temperature Requirements

The NIM CONTACT and Standard Reinforced EMG Endotracheal Tubes may obstruct the patient’s airway.
Read more: Medtronic Recalls NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube for Risk of Airway Obstruction

The FDA is informing patients and health care providers that pulse oximeters have limitations and a risk of inaccuracy that must be considered.
Read more: Pulse Oximeter Accuracy and Limitations: FDA Safety Communication

The Clearlink Basic Solution Set with Duovent may begin to leak, which poses risk of serious injury or death.

Read more: Baxter Healthcare Corporation Recalls Clearlink Basic Solution Set with Duovent for Risk of Leaks That May Expose Providers and Patients to Hazardous / Toxic Substances

FDA and NIH launch Critical Path for Rare Neurodegenerative Diseases – a public-private partnership aimed at advancing the understanding of rare neurodegenerative diseases and fostering the development of treatments.
Read more: FDA and NIH Launch Public-Private Partnership for Rare Neurodegenerative Diseases

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: September 13, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: September 9, 2022

Today, the FDA issued a safety communication about reports of SCC and various lymphomas in the capsule or scar tissue around breast implants.
Read more: FDA Issues Safety Alert for Squamous Cell Carcinoma and Various Lymphomas in Scar Tissue around Breast Implants

There are reports of clip lock malfunctions before and after clip deployment with the Abbott MitraClip device.
Read more: Abbott MitraClip Device: Potential for Clip Lock Malfunctions - Letter to Health Care Providers

Reports of squamous cell carcinoma and various lymphomas in capsule around breast implants. Read recommendations for patients and health care providers
Read more: Breast Implants: Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants: FDA Safety Communication

The FDA issued an EUA, guidance and associated templates today to help expand testing capacity in response to the monkeypox public health emergency (PHE).
Read more: Monkeypox Update: FDA Takes Significant Action to Help Expand Access to Testing

Pittsburgh, Pennsylvania – Royal Philips’ (NYSE: PHG; AEX: PHIA) subsidiary Philips Respironics is alerting users of certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or straps that these devices should not be used by or near patients and their household members, caregivers and
Read more: Philips Respironics Alerts Customers Worldwide of Updated Instructions and Labeling of Specific Sleep Therapy Masks That Contain Magnetic Headgear Clips Due to Potential Risk of Serious Injury

Today, the U.S. Food and Drug Administration alerted patients, caregivers and health care providers of recalled Philips Respironics masks for BiPAP, CPAP machines.
Read more: Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: September 6, 2022

Certain Philips masks can cause potential injury or death if magnets interfere with certain implanted metallic medical devices or metallic objects in the body.
Read more: Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: Letter to Health Care Providers

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: September 2, 2022

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