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 have another quick update on a recent FDA cancer drug approval. On June 16, 2021, the FDA approved avapritinib (brand name…
Individual Sentenced To 72 Months For Conspiracy To Possess With Intent To Distribute Fentanyl, Cocaine, And Heroin
Department of JusticeU.S. Attorney’s OfficeDistrict of Puerto Rico FOR IMMEDIATE RELEASEWednesday, June 23, 2021 SAN JUAN, Puerto Rico – Defendant Bryan Gilbert Díaz-De Jesús, a.k.a. “Bryan Gilbert De Jesús,” was sentenced today to 72 months (6 years) in prison for conspiracy to distribute controlled substances, possession with intent to distribute controlled substances, introduction of misbranded…
Pair Plead Guilty to Kickback Scheme
Department of JusticeU.S. Attorney’s OfficeWestern District of Virginia FOR IMMEDIATE RELEASEMonday, June 21, 2021 ABINGDON, Va. – A Miami, Florida man pleaded guilty last week to conspiring with a Bristol, Tennessee man to pay and receive kickbacks. According to court documents, Michael Olshavsky, 51, of Miami, Florida, and John Paul Linke, 57, of Bristol, Tenn., conspired…
Prairie Wolf Spirits, Inc. Issues Voluntary Nationwide Recall of Prairie Wolf Distillery Hand Sanitizer Packed in 16.9 Oz. and 20 Oz Bottles Because They Resemble Drink Containers
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)….
Bea Lydecker’s Naturals, Inc. Issues Allergy Alert on Undeclared Soy Lecithin in Living Free Dietary Supplement
Summary Company Announcement Date: June 21, 2021 FDA Publish Date: June 22, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Does not declare soy lecithin Company Name: Bea Lydecker’s Naturals, Inc. Brand Name: Brand Name(s) Living Free Product Description: Product Description dietary supplement products Company Announcement Bea Lydecker’s Naturals, Inc. of…
Former Supplement Company Owner Pleads Guilty to Unlawful Distribution of Anabolic Steroids and Steroid-Like Drugs
U.S. Department of Justice FOR IMMEDIATE RELEASEThursday, June 21, 2021 A Georgia resident and his company pleaded guilty today to a felony charge relating to the distribution of anabolic steroids and steroid-like drugs in purported dietary supplements. According to court documents, James Chadwick Brooks, 41, of Norcross, and his company, CCB Nutrition LLC, pleaded guilty…
Cuisine Solutions Issues Voluntary Recall of Flavored Plant-Based Bites
Summary Company Announcement Date: June 19, 2021 FDA Publish Date: June 20, 2021 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared milk and egg Company Name: Cuisine Solutions Brand Name: Brand Name(s) Product Description: Product Description Egg flavored plant-based “bites” Company Announcement Cuisine Solutions, Sterling, VA is initiating a voluntary…
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…