The U.S. Food and Drug Administration (FDA) is alerting health care providers to the possibility that patients who have the Medtronic Heartware Ventricular Assist Device (HVAD) System and appear to present with pump thrombosis may have a welding defect in the internal pump causing the pump to malfunction. This week, Medtronic issued an Urgent Medical…
Strauss Israel Announces Voluntary Recall of Certain Confectionery Products Because of Possible Health Risk
161454 ELITE HAZELNUT & ALMOND MILK CHOCOLATE BAR 77245110825 100 g 161406 ELITE MILK CHOCOLATE BAR WITH STRAWBERRY CREAM 815871010283 100 g 161405 ELITE POPPING ROCKS MILK CHOCOLATE BAR 815871010337 100/90 g 161429 ELITE WHITE CHOCOLATE BAR 815871011471 100 g 161457 ELITE WHITE CHOCOLATE BAR 815871012799 161453 ELITE MILK CHOCOLATE WITH BERRY FLAVOR TRUFFLE…
Gorton’s Issues Voluntary Recall for Small Quantity of Fish Sandwich Fillets
Summary Company Announcement Date: April 27, 2022 FDA Publish Date: April 28, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Presence of bone fragments Company Name: Gorton’s Seafood Brand Name: Brand Name(s) Gorton’s Product Description: Product Description Fish Sandwich Company Announcement Gloucester, MA (April 27, 2022) Gorton’s Seafood is voluntarily recalling…
Potential Risk of Airway Obstruction When Using Certain Electromyogram Endotracheal Tubes – Letter to Health Care Providers
April 27, 2022 The U.S. Food and Drug Administration (FDA) is evaluating the potential risk of airway obstruction when using silicone-based electromyogram (EMG) endotracheal tubes (Medtronic NIM Standard Reinforced EMG Endotracheal Tube and Medtronic NIM Contact Reinforced EMG Endotracheal Tube). The FDA has received reports describing serious adverse events and deaths for these devices after…
FDA D.I.S.C.O. Burst Edition: FDA approval of Vijoice (alpelisib) for adult and pediatric patients two years of age and older with severe manifestations of PIK3CA-related overgrowth spectrum who require systemic therapy
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 another quick update on a recent FDA cancer drug approval. On April 5, 2022, the FDA granted accelerated approval to…
Medtronic Recalls Harmony Delivery Catheter, Part of Transcatheter Pulmonary Valve (TPV) System, for Risk of Capsule Break During Use
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: Harmony Delivery Catheter System Product Codes and Batch Numbers: See database entry. Distribution Dates: April 7, 2021 to January 26, 2022 Devices Recalled in the…
Pfizer Voluntary Nationwide Recall of Lots of ACCUPRIL® (Quinapril HCl) Due to N-Nitroso-Quinapril Content
Summary Company Announcement Date: April 22, 2022 FDA Publish Date: April 22, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to N-Nitroso-Quinapril Content Company Name: Pfizer Brand Name: Brand Name(s) Product Description: Product Description Accupril (Quinapril HCl) tablets 10mg, 20mg, 40 mg Company Announcement FOR IMMEDIATE RELEASE – NEW YORK, NY., April…
Produce Packaging, Inc. Recalls Red Curry Grain Bowl and Barcelona Vinaigrette Grain Bowl Because of Possible Health Risk
Summary Company Announcement Date: April 21, 2022 FDA Publish Date: April 21, 2022 Product Type: Food & Beverages Prepared Food Allergens Reason for Announcement: Recall Reason Description Undeclared wheat Company Name: Produce Packaging, Inc. Brand Name: Brand Name(s) Produce Packaging, Inc. Product Description: Product Description Red Curry Grain Bowl and Barcelona Vinaigrette Grain Bowl Company…
FDA D.I.S.C.O. Burst Edition: FDA approval Yescarta (axicabtagene ciloleucel) for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy
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 a recent FDA cancer therapeutic approval. On April 1, 2022, the FDA approved axicabtagene ciloleucel (brand…
Justice Department Announces Nationwide Coordinated Law Enforcement Action to Combat Health Care-Related COVID-19 Fraud
U.S. Department of Justice FOR IMMEDIATE RELEASEWednesday, April 20, 2022 Criminal Charges Brought Against Owners and Executives of Medical Businesses, Physicians, Marketers, and Manufacturers of Fake COVID-19 Vaccination Record Cards with Losses Exceeding $149 Million The Department of Justice today announced criminal charges against 21 defendants in nine federal districts across the United States for their…