Summary Company Announcement Date: September 29, 2022 FDA Publish Date: September 29, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Label Mix-up Company Name: Golden State Medical Supply, Incorporated Brand Name: Brand Name(s) Golden State Medical Supply, Incorporated Product Description: Product Description Clopidogrel 75mg Tablets, Atenolol 25mg Tablets Company Announcement FOR…
Proper Trade LLC/My Stellar Lifestyle Issues Voluntary Nationwide Recall of Wonder Pill Capsules Due to the Presence of Undeclared Tadalafil
Summary Company Announcement Date: September 27, 2022 FDA Publish Date: September 28, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains undeclared tadalafil Company Name: Proper Trade LLC/My Stellar Lifestyle Brand Name: Brand Name(s) My Stellar Lifestyle Product Description: Product Description Wonder Pill Capsules Company Announcement Proper Trade LLC/My Stellar Lifestyle is…
FDA D.I.S.C.O. Burst Edition: FDA approvals of Imbruvica (ibrutinib) for pediatric patients with chronic graft versus host disease, and Pemazyre (pemigatinib) for adults with relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on two recent FDA cancer drug approvals. On August 24, 2022, the FDA approved ibrutinib (brand name…
A Fresh Take on What “Healthy” Means on Food Packages
With so many food options out there, it is helpful to have information on food packages that can empower you to identify healthier choices. The U.S. Food and Drug Administration is proposing to update its definition of “healthy.” That includes the nutritional criteria a product must meet to put the claim “healthy” on the package….
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
Summary Company Announcement Date: September 27, 2022 FDA Publish Date: September 27, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of a dark red, brown and black particulate inside the vial Company Name: Eugia US LLC Brand Name: Brand Name(s) Auromedics Product Description: Product Description Acyclovir Intravenous Product Company Announcement FOR IMMEDIATE…
Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern
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 Product Name: Philips Respironics BiPAP A30, A40, V30, and OmniLab Advanced+ Product Models: A-Series BiPAP A30 (Ventilator) A-Series BiPAP A40 (Ventilator) A-Series BiPAP V30 (Auto Ventilator) OmniLab…
Salon Technologies, Inc. Issues Voluntary Nationwide Recall of Antica Ocean Citron Hand Sanitizer ( Alcohol ) Gel 65% Due to the Presence of Benzene
Summary Company Announcement Date: September 17, 2022 FDA Publish Date: September 19, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains benzene Company Name: Salon Technologies International Inc. Brand Name: Brand Name(s) Antica Farmacista Product Description: Product Description Ocean Citron Hand Sanitizer Company Announcement FOR IMMEDIATE RELEASE – September 16, 2022 –…
Medtronic Recalls NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube for Risk of Airway Obstruction
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 Product Name: NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube Model Numbers: See recall database entry Devices Being Recalled in the…
Voluntary Recall of Certain Colgate Products Sold at Family Dollar Stores Because They Were Stored Outside of Temperature Requirements
Summary Company Announcement Date: September 15, 2022 FDA Publish Date: September 16, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Product was stored outside of labeled temperature requirements Company Name: Family Dollar Brand Name: Brand Name(s) Product Description: Product Description Toothpaste Company Announcement Family Dollar is initiating a voluntary retail level product recall…
Update: Recommendations for Certain Medtronic Electromyogram Endotracheal Tubes and Risk of Airway Obstruction – Letter to Health Care Providers
September 16, 2022 The U.S. Food and Drug Administration (FDA) is updating the Letter to Health Care Providers issued on April 27, 2022, to ensure health care providers in the operating room setting are aware of the voluntary recall initiated by Medtronic for the risk of airway obstruction with the NIM CONTACT Reinforced EMG Endotracheal…