Summary Company Announcement Date: March 16, 2021 FDA Publish Date: March 16, 2021 Product Type: Animal & VeterinaryFood & Beverages Pet Food Foodborne Illness Reason for Announcement: Recall Reason Description Due to Potential Salmonella and Listeria monocytogenes Company Name: Bravo Packing, Inc. Brand Name: Brand Name(s) Bravo Packing, Inc. Product Description: Product Description Pet food:…
Radiation-Emitting Products
From medical X-ray scanners used to see inside the body to surgical lasers used for cosmetic purposes or to improve eyesight, FDA ensures the safety and effectiveness of a wide range or products that emit radiation. To learn more, read these Consumer Updates. Content current as of: 04/22/2019 Regulated Product(s) Article source: http://www.fda.gov/consumers/consumer-updates/radiation-emitting-products
PNHC, LLC d/b/a Heal the World Issues Voluntary Nationwide Recall of Heal the World Hand Sanitizer Packaged in 9.6 Ounce Bottles Because They Resemble Small Water Bottles
Summary Company Announcement Date: March 16, 2021 FDA Publish Date: March 17, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Because they resemble water bottles; risk of ingestion Company Name: PNHC, LLC d/b/a Heal the World Brand Name: Brand Name(s) Heal the World Product Description: Product Description Hand Sanitizer Company Announcement Raleigh, North…
Operators of Dietary Supplement Company Plead Guilty to Failure to Register a Food Manufacturing Facility and Refusal of an FDA Inspection
Department of JusticeU.S. Attorney’s OfficeNorthern District of Ohio FOR IMMEDIATE RELEASEMonday, March 15, 2021 The operators of a dietary supplement manufacturing company in Monroeville and Canton, Ohio, pleaded guilty in federal court today to a bill of information charging them with failure to register a food manufacturing facility and refusal of a U.S. Food and Drug Administration…
Risk of Device Component Breaking in Patients with Stryker’s STAR Ankle: FDA Safety Communication
Date Issued: March 15, 2021 The U.S. Food and Drug Administration (FDA) is advising patients, caregivers, and health care providers about the higher than expected risk of the polyethylene (plastic) component of the device breaking (fracture), as early as three to four years after implantation in all Scandinavian Total Ankle Replacement devices (STAR Ankle). Fracture…
Potential for False Results with Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza Test for use on cobas Liat System-Letter to Clinical Laboratory Staff, Point-of-Care Facility Staff, and Health Care Providers
The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff, point-of-care (POC) facility staff, and health care providers that false positive results can occur with the Roche Molecular Systems, Inc. (Roche) cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System. The false positive results may be related…
Allergy Alert Issued for Undeclared Tree Nuts in Mislabeled Cranberry Biscotti at Six Whole Foods Market Stores
Summary Company Announcement Date: March 11, 2021 FDA Publish Date: March 12, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared tree nuts (pistachio) Company Name: Whole Foods Market Brand Name: Brand Name(s) Whole Foods Market Product Description: Product Description Cranberry Biscotti Company Announcement Whole Foods Market is voluntarily recalling Cranberry…
Combat Medical Systems, LLC, Recalls Valkyrie LTOWB Collection, Valkyrie LTOWB Administration, Low Titer Type O FWB Transfusion Set, Fresh Whole Blood Transfusion Set, Fresh Whole Blood Donor Set for Possible Broken or Bent Needles
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 Products Combat Medical Convenience Kits: Valkyrie LTOWB Collection and Administration Models: 80-820, NSN 6515016862423 and 80-821 NSN 6515016862401 Low Titer Type O FWB Transfusion Set and Low Titer…
Sagent Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Phenylephrine Hydrochloride Injection, USP, 10 mg/mL Due to Potential Lack of Sterility Assurance
Summary Company Announcement Date: March 11, 2021 FDA Publish Date: March 11, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Lack of sterility assurance Company Name: Sagent Pharmaceuticals, Inc. Brand Name: Brand Name(s) Product Description: Product Description Phenylephrine Hydrochloride Injection Company Announcement Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of three…
Know Your Treatment Options for COVID-19
[embedded content] Patients today have more treatment options in the battle against coronavirus disease. The U.S. Food and Drug Administration has approved one drug treatment for COVID-19 and has authorized others for emergency use during this public health emergency. In addition, many more therapies are being tested in clinical trials to evaluate whether they are…