The recall described in this notice is for the same issue that was announced in Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue FDA Safety Communication on October 5, 2021. The FDA has identified this as a Class I recall, the most serious type of…
Staten Island Businessman Operating in Bucks County Sentenced to One Year in Prison for Tobacco Smuggling
Department of JusticeU.S. Attorney’s OfficeEastern District of Pennsylvania FOR IMMEDIATE RELEASETuesday, November 3, 2021 PHILADELPHIA – Acting United States Attorney Jennifer Arbittier Williams announced that Ramzi Al Najar, 43, of Staten Island, NY, was sentenced to one year and one day in prison, three years of supervised release, and ordered to pay over $7.8 million…
Aligned Medical Solutions Doing Business as Windstone Medical Packaging, Inc. Recalls Custom Convenience Kits Due to Cardinal Health Monoject Flush Prefilled Syringe (0.9% Sodium Chloride) Plunger Defect
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 (Include the following information) Product Names: Custom Convenience Kits containing the Cardinal Health Monoject Flush Prefilled Syringe including: Leaderflex Insertion Kit with Ultrasound, Insertion Tray-RX, Universal Procedure…
FDA D.I.S.C.O. Burst Edition: FDA approval of Scemblix (asciminib) for patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, previously treated with tyrosine kinase inhibitors, and for adult patients in chronic phase with the T315I mutation
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 drug approval. On October 29, 2021, the FDA granted accelerated approval to…
Nutracap Holdings, LLC Issues Voluntary Recall of Various Dietary Supplements Due to Undeclared Wheat, Milk, Soy and/or Coconut
Summary Company Announcement Date: November 09, 2021 FDA Publish Date: November 09, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared wheat, milk, soy and/or coconut Company Name: Nutracap Holdings, LLC Brand Name: Brand Name(s) Etedream, Vital Force, Raw, Boba Origin, Steel Product Description: Product Description Dietary Supplement Protein Powder Company…
Southeastern Grocers Recalls Fisherman’s Wharf Brand Jumbo Cooked Shrimp, Frozen 16-20 Count, Due to Possible Health Risk
Summary Company Announcement Date: November 03, 2021 FDA Publish Date: November 05, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Possible Listeria Company Name: Southeastern Grocers Brand Name: Brand Name(s) Fisherman’s Wharf Product Description: Product Description Jumbo Cooked Shrimp, Frozen Company Announcement JACKSONVILLE, Fla. (Nov. 2, 2021) – Southeastern Grocers (SEG),…
Doctor Who Distributed Unapproved Cancer Treatment Drug Convicted of More Than Two Dozen Felony Charges
Department of JusticeU.S. Attorney’s OfficeCentral District of California FOR IMMEDIATE RELEASEWednesday, November 3, 2021 SANTA ANA, California – A physician has been found guilty of 26 felony charges for fraudulently distributing an unapproved cancer treatment over a six-year period, charging up to $2,000 per bottle, the Justice Department announced today. Benedict Liao, 81, a.k.a. “Wada…
Couple with Ties to the Fitness Industry Admits Distributing Unapproved Drugs
Department of JusticeU.S. Attorney’s OfficeWestern District of Pennsylvania FOR IMMEDIATE RELEASEWednesday, November 3, 2021 PITTSBURGH, PA – Two residents of Pittsburgh, Pennsylvania, pleaded guilty in federal court to a charge of conspiring to defraud the United States, Acting United States Attorney Stephen R. Kaufman announced today. Thomas Mouton, age 34, and Sara Mouton, age 36,…
Pier-C Produce Inc. Recalls 2 lb White Onions – Product of Mexico Because of Possible Health Risk
Summary Company Announcement Date: November 04, 2021 FDA Publish Date: November 04, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential Salmonella Company Name: Pier-C Produce Inc Brand Name: Brand Name(s) Pier-C Produce Product Description: Product Description Whole White Onions Company Announcement Pier-C Produce Inc. of Leamington, Ontario Canada is voluntarily…
Amended – Flowers Foods Issues Voluntary Recall on Certain Tastykake Products Due to Possible Presence of Tiny Fragments of Metal Mesh Wire
Summary Company Announcement Date: November 03, 2021 FDA Publish Date: November 04, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description May contain metal mesh wire Company Name: Flowers Foods, Inc. Brand Name: Brand Name(s) Product Description: Product Description Cupcakes and Krimpets Company Announcement THOMASVILLE, Ga. – Flowers Foods, Inc. (NYSE: FLO)…