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 HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief Model Numbers: HVAD™ Pump Outflow Graft: 1125 HVAD™ Pump Implant Kit: 1103 HVAD™ Implant Accessories Kit: 1153…
Viable Solutions, LLC Recalls Certain Kratom-Containing Powder Products Because of Possible Health Risk
Summary Company Announcement Date: April 06, 2020 FDA Publish Date: April 06, 2020 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Salmonella Company Name: Viable Solutions Brand Name: Brand Name(s) Herbal-Salvation Product Description: Product Description Kratom containing powder products Company Announcement Viable Solutions ofNampa, ID has initiated a recall of…
Use the Correct Cycle and Compatible N95 Respirators When Decontaminating Respirators with STERRAD Sterilization Systems – Letter to Health Care Providers
The U.S. Food and Drug Administration (FDA) reminds reprocessing staff in health care facilities to use the correct decontamination cycle associated with certain models of the Advanced Sterilization Products (ASP) STERRAD Sterilization Systems and to only decontaminate compatible N95 or N95-equivalent respirators for reuse during the COVID-19 pandemic. ASP STERRAD Sterilization Systems use vaporized hydrogen…
Akron Man Indicted for Possession with Intent to Distribute THC Vape Cartridges and Illegal Firearm Possession
Department of JusticeU.S. Attorney’s OfficeNorthern District of Ohio FOR IMMEDIATE RELEASEThursday, May 21, 2020 The U.S. Attorney’s Office for the Northern District of Ohio announced today that a federal grand jury in Cleveland returned a three-count indictment charging Justin Michl, age 23, of Akron with intent to distribute Tetrahydrocannabinol (THC), possession of firearms in furtherance of…
Johnson Sea Products Issues Allergy Alert on Undeclared Wheat & Soy in “Home Style Crab Cakes”
Summary Company Announcement Date: May 22, 2020 FDA Publish Date: May 26, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared wheat and soy Company Name: Johnson Sea Products Brand Name: Brand Name(s) Johnson Sea Products Product Description: Product Description Crab cakes Company Announcement Johnson Sea Products of Coden, AL, is…
Akron Man Indicted for Possession with Intent to Distribute THC Vape Cartridges and Illegal Fireman Possession
Department of JusticeU.S. Attorney’s OfficeNorthern District of Ohio FOR IMMEDIATE RELEASEThursday, May 21, 2020 The U.S. Attorney’s Office for the Northern District of Ohio announced today that a federal grand jury in Cleveland returned a three-count indictment charging Justin Michl, age 23, of Akron with intent to distribute Tetrahydrocannabinol (THC), possession of firearms in furtherance of…
Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Super Potency
Summary Company Announcement Date: May 22, 2020 FDA Publish Date: May 22, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Super potency Company Name: Acella Pharmaceuticals, LLC Brand Name: Brand Name(s) Product Description: Product Description 30-mg, 60-mg and 90-mg NP Thyroid® Company Announcement Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13…
New Hoque and Sons, Inc. Recalls Radhuni Curry Powder Because of Possible Health Risk
Summary Company Announcement Date: May 21, 2020 FDA Publish Date: May 21, 2020 Product Type: Food & Beverages Spices, Flavors & Salts Foodborne Illness Reason for Announcement: Recall Reason Description Salmonella Company Name: New Hoque and Sons, Inc. Brand Name: Brand Name(s) Product Description: Product Description Curry Powder Company Announcement New Hoque and Sons, Inc. of…
Biota Biosciences Issues Voluntary Nationwide Recall of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables Because They Were Marketed Without FDA Approval
Summary Company Announcement Date: May 20, 2020 FDA Publish Date: May 20, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Unapproved new drug Company Name: Biota Biosciences, LLC Brand Name: Brand Name(s) Biota Biosciences Product Description: Product Description Cannabidiol (CBD) Complex, Curcumin Complex, Cannabidiol + Curcumin Company Announcement Biota Biosciences is voluntarily recalling…
Mellace Family Brands California Inc. (Johnvince Foods) Recalls Wegmans Semi-Sweet Chocolate nonpareils, 18.5oz (1lb 2.5oz) 524g Due to Undeclared Milk Allergen
Summary Company Announcement Date: May 14, 2020 FDA Publish Date: May 15, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Milk Company Name: MELLACE FAMILY BRANDS CALIFORNIA INC. Brand Name: Brand Name(s) Product Description: Product Description Semi-Sweet Chocolate nonpareils Company Announcement MELLACE FAMILY BRANDS CALIFORNIA INC. (JOHNVINCE FOODS),located at 655…