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…
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…
Bucks County Drug Manufacturer and Two Executives Charged with Conspiracy to Defraud the FDA
Department of JusticeU.S. Attorney’s OfficeEastern District of Pennsylvania FOR IMMEDIATE RELEASEFriday, June 11, 2021 KVK-TECH, Inc., Murty Vepuri and Ashvin Panchal Allegedly Distributed Unapproved Drugs and Lied to Drug Regulators PHILADELPHIA – Acting United States Attorney Jennifer Arbittier Williams announced that generic drug manufacturer KVK-TECH, Inc., headquartered in Newtown, PA, Murty Vepuri (69), and Ashvin Panchal,…
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…
Additional Co-Conspirators Charged in Prescription Diversion Scheme
Department of JusticeU.S. Attorney’s OfficeSouthern District of Florida FOR IMMEDIATE RELEASEFriday, June 11, 2021 Miami, Florida – A South Florida grand jury has charged five additional defendants for their alleged roles in a sophisticated scheme to purchase and distribute millions of dollars in diverted pharmaceutical drugs. A total of 14 defendants have now been charged…
Designed By Nature Voluntarily Recalls Goat’s Milk, Cow’s Milk and Base Milk Formulas Due to Possible Health Risk
Summary Company Announcement Date: June 14, 2021 FDA Publish Date: June 14, 2021 Product Type: Food & Beverages Milk/Milk Product Reason for Announcement: Recall Reason Description Products are not intended to be used as infant formula Company Name: Designed by Nature Brand Name: Brand Name(s) Designed by Nature Product Description: Product Description Goat Milk, Cow…