Summary Company Announcement Date: February 08, 2022 FDA Publish Date: February 08, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Tadalafil Company Name: Your Favorite Shop Brand Name: Brand Name(s) Your Favorite Shop Product Description: Product Description The Red Pill Company Announcement FOR IMMEDIATE RELEASE – 2/8/2022 – Jackson, NJ – Your…
Celebrate Today Issues Voluntary Nationwide Recall of One Lot of Red Mammoth Due to the Presence of Undeclared Sildenafil and Tadalafil
Summary Company Announcement Date: February 08, 2022 FDA Publish Date: February 09, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil and Tadalafil Company Name: Celebrate Today Brand Name: Brand Name(s) Celebrate Today Product Description: Product Description Red Mammoth capsules Company Announcement FOR IMMEDIATE RELEASE – 02/08/2022 – Brentwood, NY, Celebrate Today…
Potential Risk of Strangulation in Children who Use Enteral Feeding Delivery Sets
Date Issued: February 8, 2022 The U.S. Food and Drug Administration (FDA) is warning health care providers, parents and caregivers of pediatric patients (children) who receive enteral feeding that there is a risk of strangulation from the use of enteral feeding delivery sets. The feeding set tubing can become wrapped around a child’s neck and…
Vyaire Medical Issues Voluntary Correction for Certain bellavista™ Ventilators in Specific Software Configurations
Summary Company Announcement Date: February 04, 2022 FDA Publish Date: February 04, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Ventilators can cease ventilation and generate a technical failure alarm 305 Company Name: Vyaire Medical Brand Name: Brand Name(s) bellavista™ Product Description: Product Description ventilators Company Announcement CHICAGO, February 4, 2022—In December…
SD BIOSENSOR, Issues Notification of Voluntary Recall of ‘STANDARD Q COVID-19 Ag Home Test’
Summary Company Announcement Date: February 02, 2022 FDA Publish Date: February 04, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description illegally imported into the United States Company Name: SD Biosensor, Inc. Brand Name: Brand Name(s) SD Biosensor, Inc. Product Description: Product Description STANDARD Q COVID-19 Ag Home Test Company Announcement January 31,…
Do Not Use E25Bio COVID-19 Tests: FDA Safety Communication
Date Issued: February 4, 2022 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…
Junp LLC Issues Voluntary Nationwide Recall of MegMan Performance Booster Capsules Due to the Presence of Tadalafil
Summary Company Announcement Date: February 04, 2022 FDA Publish Date: February 04, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Tadalafil Company Name: Junp LLC Brand Name: Brand Name(s) Product Description: Product Description MegMan Performance Booster capsules Company Announcement FOR IMMEDIATE RELEASE – 2/3/2022– Brooklyn, NY Junp LLC is voluntarily recalling Lot…
Ukoniq (umbralisib): Drug Safety Communication – FDA Investigating Possible Increased Risk of Death with Lymphoma
[Posted 02/03/2022] AUDIENCE: Oncology, Patient, Health Professional, Pharmacy ISSUE: The FDA is investigating a possible increased risk of death with the cancer medicine Ukoniq (umbralisib) approved to treat two specific types of lymphomas, which are cancers that affect the body’s immune system. The FDA determined that initial findings from a clinical trial evaluating Ukoniq to treat a related…
Esupplementsales, LLC Issues a Nationwide Recall of One Lot of Hard Dawn Due to the Presence of Undeclared Tadalafil
Summary Company Announcement Date: January 28, 2022 FDA Publish Date: January 31, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Tadalafil Company Name: Esupplementsales, LLC Brand Name: Brand Name(s) Product Description: Product Description Hard Dawn Rise and Shine capsules Company Announcement FOR IMMEDIATE RELEASE – 01/28/2022 – Orangevale, CA, Esupplementsales, LLC is…
Philips Respironics CPAP, BiPAP, and Ventilator Recalls: Frequently Asked Questions
In June 2021, Philips Respironics voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP), and continuous positive airway pressure (CPAP) machines due to potential health risks. The polyester-based polyurethane foam used in these medical devices to lessen sound and vibration can break down. If this occurs, black pieces…