Summary Company Announcement Date: June 21, 2021 FDA Publish Date: June 22, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Packaged in containers resembling water bottles Company Name: Prairie Wolf Spirits, Inc. Brand Name: Brand Name(s) Prairie Wolf Distillery Product Description: Product Description Hand sanitizer packaged in 16.9 fluid ounce and 20 fluid…
Sanit Technologies Adds Label Clarification to Existing Voluntary Hand Sanitizer Recall
Summary Company Announcement Date: June 19, 2021 FDA Publish Date: June 22, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination Company Name: Sanit Technologies LLC d/b/a Durisan Brand Name: Brand Name(s) Product Description: Product Description Hand sanitizer and hand sanitizing wipes Company Announcement Sanit Technologies LLC d/b/a Durisan, is providing an…
Las garrapatas y la enfermedad de Lyme: síntomas, tratamiento y prevención
[embedded content] English Las enfermedades transmitidas por las garrapatas, como la enfermedad de Lyme, están proliferando. Los casos reportados en los Estados Unidos aumentaron, de unos 12,000 al año en 1995, a aproximadamento 36,000 del 2013 al 2016, según los Centros para el Control y la Prevención de Enfermedades (CDC, por sus siglas en inglés)….
Smiths Medical Issues Worldwide Notification Regarding the Recall of Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringe With Skewed Graduation Markings
Summary Company Announcement Date: June 16, 2021 FDA Publish Date: June 17, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Skewed odd number line graduation markings on syringe barrels. Company Name: Smiths Medical Brand Name: Brand Name(s) Product Description: Product Description Hypodermic Needle-Pro Fixed Needle Insulin Syringes Company Announcement Smiths Medical has…
How to Report Problems with Flea and Tick Products
Image Fleas and ticks can be more than just an itchy annoyance to your pets—they can cause serious harm. So it’s important to know how to use flea and tick products safely. It’s also important to know whom to report to if you’re experiencing problems with these products. Flea and tick products for pets are…
FDA D.I.S.C.O. Burst Edition: FDA approvals of Lumakras (sotorasib) for patients with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer, and Truseltiq (infigratinib) for unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on two recent FDA cancer drug approvals. On May 28, 2021, FDA granted accelerated approval to sotorasib…
Infusion Pump Repair Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts
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 Alaris Infusion Pump Module Model 8100 Bezel, purchased and/or installed by Infusion Pump Repair Models: Alaris Model 8100 Product Number: TIPA-8100-4410 Lot Number: 20200608 Devices Recalled in…
Philips Issues a Recall Notification* to Mitigate Potential Health Risks Related to the Sound Abatement Foam Component in Certain Sleep and Respiratory Care Devices
Summary Company Announcement Date: June 14, 2021 FDA Publish Date: June 15, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices Company Name: Philips Brand Name: Brand Name(s) Product Description: Product Description Philips Bi-Level Positive Airway Pressure…
Older Therapies Aren’t Necessarily Better for Thyroid Hormone Replacement
Image Millions of people have thyroid glands that don’t make enough thyroid hormone to meet their body’s needs. Hypothyroidism, also called underactive thyroid, is the most common reason some people need thyroid hormone replacement. Hypothyroidism is treated by replacing the hormones that your own thyroid can no longer make. Thyroid hormone medicines mimic these hormones….
Sodium Citrate Blood Specimen Collection Tube Conservation Strategies – Letter to Health Care and Laboratory Personnel
June 10, 2021 The U.S. Food and Drug Administration (FDA) is aware that the U.S. is experiencing significant interruptions in the supply of sodium citrate blood specimen collection (light blue top) tubes because of an increase in demand and recent vendor supply challenges. Recommendations The FDA recommends that health care providers, laboratory directors, phlebotomists, and…