Florida Medical Doctor Pleads Guilty to Conspiring to Falsify Clinical Trial Data

    U.S. Department of Justice  FOR IMMEDIATE RELEASEFriday, January 8, 2021 A Florida medical doctor pleaded guilty to conspiring to falsify clinical trial data regarding an asthma medication, the Department of Justice announced today. Dr. Yvelice Villaman Bencosme, 64, of Miami, Florida, pleaded guilty in U.S. District Court for the Southern District of Florida today to one count…

    Lavva Voluntarily Recalls a Single Lot of Blueberry Plant-Based Yogurt

    Summary Company Announcement Date: January 11, 2021 FDA Publish Date: January 11, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential for Mold Company Name: EVR Foods Inc. Brand Name: Brand Name(s) Product Description: Product Description Blueberry Plant-Based Yogurt Company Announcement Recall Limited to Lavva Blueberry Plant-Based Yogurt 5.3 Ounce Dated…

    Midwestern Pet Foods Voluntarily Expands Recall of Pet Food for Aflatoxin Health Risk

    Summary Company Announcement Date: January 11, 2021 FDA Publish Date: January 11, 2021 Product Type: Animal & VeterinaryFood & Beverages Pet Food Reason for Announcement: Recall Reason Description Aflatoxin Levels Exceed Acceptable Levels Company Name: Midwestern Pet Foods Inc. Brand Name: Brand Name(s) Sportmix, Nunn Better, ProPac, and Others Product Description: Product Description Dog and…

    Boston Scientific Announces LOTUS Edge™ Aortic Valve System Voluntary Recall and Product Discontinuation

    Summary Company Announcement Date: January 11, 2021 FDA Publish Date: January 11, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Delivery System Issues Potential inability to release the delivery system Company Name: Boston Scientific Corporation Brand Name: Brand Name(s) LOTUS Edge™ Aortic Valve System Product Description: Product Description LOTUS Edge™ Aortic Valve…

    Weis Markets Issues Recall for Possible Foreign Matter Contamination in Weis Ice Cream Products

    Summary Company Announcement Date: January 08, 2021 FDA Publish Date: January 10, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description May be contaminated with extraneous material Company Name: Weis Markets Brand Name: Brand Name(s) Weis, Klein’s, Nelson’s Product Description: Product Description Ice cream products Company Announcement Weis Markets today said it…

    What Is Gene Therapy? How Does It Work?

    [embedded content] Español The genes in your body’s cells play an important role in your health — indeed, a defective gene or genes can make you sick. Recognizing this, scientists have been working for decades on ways to modify genes or replace faulty genes with healthy ones to treat, cure or prevent a disease or…

    Genetic Variants of SARS-CoV-2 May Lead to False Negative Results with Molecular Tests for Detection of SARS-CoV-2 – Letter to Clinical Laboratory Staff and Health Care Providers

    January 8, 2021 The SARS-CoV-2 virus can mutate over time, resulting in genetic variation in the population of circulating viral strains. The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers that false negative results may occur with any molecular test for the detection of SARS-CoV-2 if a mutation…

    Birmingham Man Pleads Guilty to Conspiracy for Making Unapproved Drug Products in His Kitchen and Warehouse

    Department of JusticeU.S. Attorney’s OfficeNorthern District of Alabama FOR IMMEDIATE RELEASEThursday, January 7, 2021 BIRMINGHAM, Ala. – A Birmingham man today pleaded guilty to making unapproved drug products in his kitchen and warehouse, and marketing and selling them as a cancer treatment, announced U.S. Attorney Prim F. Escalona and U.S. Food and Drug Administration (FDA) Office of…

    Fresenius Kabi Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter

    Summary Company Announcement Date: January 08, 2021 FDA Publish Date: January 08, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulate matter Company Name: Fresenius Kabi USA Brand Name: Brand Name(s) Fresenius Kabi Product Description: Product Description Ketorolac Tromethamine Injection, USP, 30 mg/mL Company Announcement Fresenius Kabi USA is voluntarily recalling…

    Nostrum Laboratories, Inc. Expands Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

    Summary Company Announcement Date: January 04, 2021 FDA Publish Date: January 04, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA exceeds acceptable daily intake limit Company Name: Nostrum Laboratories Brand Name: Brand Name(s) Nostrum Laboratories Product Description: Product Description Metformin HCl Extended Release Tablets, USP 750 mg Company Announcement Nostrum Laboratories, Inc….