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…
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…
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…
Bryant Ranch Prepack Issues Voluntary Nationwide Recall of Spironolactone 25 mg and 50 mg Tablets Due to Mislabeling with the Incorrect Strength
Summary Company Announcement Date: March 09, 2021 FDA Publish Date: March 09, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Incorrect strength displayed on the label Company Name: Bryant Ranch Prepack Brand Name: Brand Name(s) BRP Pharmaceuticals Product Description: Product Description Spironolactone TB 25MG and 50MG Company Announcement Bryant Ranch Prepack is voluntarily…
Why You Should Not Use Ivermectin to Treat or Prevent COVID-19
Image COVID-19. We’ve been living with it for what sometimes seems like forever. Given the number of deaths that have occurred from the disease, it’s perhaps not surprising that some consumers are looking at unconventional treatments, not approved or authorized by the Food and Drug Administration (FDA). Though this is understandable, please beware. The FDA’s…
Improper Use of Thermal Imaging Devices: FDA Safety Communication
Date Issued: March 4, 2021 The U.S. Food and Drug Administration (FDA) is alerting consumers, health care providers and other users of thermal imaging systems intended to measure human body temperature that improper use of these systems may provide inaccurate temperature readings. These devices are also known as telethermographic systems, infrared thermographs, thermal cameras, and…
Formaldehyde in Hair Smoothing Products: What You Should Know
Image If you decide that you want to make your hair less frizzy or straighter, you may choose to go to a professional stylist at a hair salon for a hair straightening or smoothing service. Most hair smoothing or straightening products release formaldehyde gas, a known human carcinogen as classified by the International Agency for…