Summary Company Announcement Date: July 08, 2020 FDA Publish Date: July 08, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description N-Nitrosodimethylamine (NDMA) Impurity Company Name: Lupin Pharmaceuticals, Inc. Brand Name: Brand Name(s) Product Description: Product Description Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg Company Announcement Lupin Pharmaceuticals Inc. is voluntarily recalling all batches…
Manager of Mobile West Michigan Urological Practice Sentenced to Prison for Role in Healthcare Fraud Scheme
Department of JusticeU.S. Attorney’s OfficeWestern District of Michigan FOR IMMEDIATE RELEASEMonday, June 29, 2020 Office Manager Mark J. Sabor Sentenced Today for Conspiracy to Commit Healthcare Fraud and Agrees to Pay Share of Civil Settlement Totaling $1.26 Million GRAND RAPIDS, MICHIGAN — U.S. Attorney Andrew B. Birge announced today that U.S. District Judge Janet T. Neff…
Father and Sons Charged in Miami Federal Court with Selling Toxic Bleach as Fake “Miracle” Cure for Covid-19 and Violating Court Orders
Department of JusticeU.S. Attorney’s OfficeSouthern District of Florida FOR IMMEDIATE RELEASEWednesday, July 8, 2020 Defendants Allegedly Attempted to Avoid Government Regulation by Selling Products Through a Company They Deceptively Named Genesis II Church Miami, Fl. – Federal prosecutors in Miami have charged four Florida residents who allegedly marketed “Miracle Mineral Solution,” a toxic bleach, as a…
Sundial Herbal Products is Recalling Products Attached Because these Products were Misbranded. The Products are Currently Unapproved Drugs, Recall is Required by the Order
Summary Company Announcement Date: July 09, 2020 FDA Publish Date: July 09, 2020 Product Type: Food & Beverages Spices, Flavors & Salts Reason for Announcement: Recall Reason Description Misbranding & Unapproved New Drugs Company Name: Sundial Herbal Products Brand Name: Brand Name(s) Product Description: Product Description Herbal Products/Dietary Supplements Company Announcement To all Stores, Vendors and…
Endologix Issues Correction Notice for Ovation iX Abdominal Stent Graft System
Summary Company Announcement Date: June 15, 2020 FDA Publish Date: July 08, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Company Name: Endologix® Inc. Brand Name: Brand Name(s) Product Description: Product Description Ovation iX system…
CME America Announces a Follow-Up on the Voluntary Recall of BodyGuard® Infusion System Administration Sets
Summary Company Announcement Date: July 03, 2020 FDA Publish Date: July 08, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Use of the pump system potentially could cause over-infusion or under-infusion of therapy Company Name: CME America Brand Name: Brand Name(s) Product Description: Product Description Infusion System Administration Set (infusion set) Company…
Allergy Alert: KIND Issues Voluntary Recall Due to Undeclared Sesame Seeds in Oats & Honey
Summary Company Announcement Date: July 07, 2020 FDA Publish Date: July 08, 2020 Product Type: Food & Beverages Nuts & Nut Products Allergens Reason for Announcement: Recall Reason Description Undeclared sesame seeds Company Name: KIND Healthy Snacks Brand Name: Brand Name(s) Product Description: Product Description Oats & Honey Granola with Toasted Coconut pouches Company Announcement…
Mylan Initiates Voluntary Nationwide Recall of One Lot of Daptomycin for Injection, Due to The Presence of Particulate
Summary Company Announcement Date: July 07, 2020 FDA Publish Date: July 07, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulate matter Company Name: Mylan Institutional LLC Brand Name: Brand Name(s) Product Description: Product Description Daptomycin for Injection Company Announcement Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional…
Three Michigan Men Indicted for Distribution of THC Vape Cartridges
Department of JusticeU.S. Attorney’s OfficeNorthern District of Ohio FOR IMMEDIATE RELEASEThursday, July 2, 2020 CLEVELAND, Ohio – A federal grand jury sitting in Cleveland, Ohio has returned a two-count indictment charging Artyom Garber, age 33, Paul Queenan, age 64 and John Botsford, age 62, all of Michigan with conspiracy to possess with the intent to distribute…
False Positive Results with BD SARS-CoV-2 Reagents for the BD Max System – Letter to Clinical Laboratory Staff and Health Care Providers
The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers of an increased risk of a false positive result with BD SARS-CoV-2 Reagents for the BD Max System test. In one study, the manufacturer found approximately three percent (3%) of results were false positive results. Recommendations The FDA recommends…