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 V60 Plus ventilators and all V60 ventilators upgraded to enable High Flow Therapy (software version 3.00 and 3.10) Distribution Dates: May 1, 2009 to June 2, 2021…
BD to Begin Remediation for BD Alaris™ System Software
Summary Company Announcement Date: July 29, 2021 FDA Publish Date: August 02, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Infusion pump may not operate as expected Company Name: Becton, Dickinson and Company Brand Name: Brand Name(s) Product Description: Product Description Alaris System Company Announcement FRANKLIN LAKES, N.J., July 29, 2021 /PRNewswire/…
Healthy Breakfasts for Kids: It’s All About Balance
[embedded content] Español A healthy breakfast is a must for kids. Skip it and your kids will be playing nutritional catch-up for the rest of the day, says Carole L. Adler, M.A., R.D., a dietitian at the Food and Drug Administration (FDA). When kids skip breakfast, they don’t get what they need to be at…
76-month federal prison sentence for Arizona man who participated in South Florida prescription medication diversion scheme
Department of JusticeU.S. Attorney’s OfficeSouthern District of Florida FOR IMMEDIATE RELEASEMonday, August 2, 2021 Miami, Florida – On Friday, a Miami federal judge sentenced a 38-year-old Arizona resident to 76 months in federal prison for his role in a sophisticated fraud scheme involving millions of dollars in diverted pharmaceutical drugs. Joshua Ryan Joles managed one…
Nature’s Sunshine Issued Allergy Alert on Undeclared Milk in its “Love & Peas” Meal Replacement Shake
Summary Company Announcement Date: July 30, 2021 FDA Publish Date: August 02, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Nature’s Sunshine Brand Name: Brand Name(s) Nature’s Sunshine Product Description: Product Description Love & Peas Protein Rich Meal Replacement Company Announcement Nature’s Sunshine of Lehi, Utah is…
Golden Natural Products Inc. Issues Allergy Alert on Undeclared Sulfites in Two Dried Apricot Products
Summary Company Announcement Date: August 02, 2021 FDA Publish Date: August 02, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared sulfites Company Name: Golden Natural Product Inc. Brand Name: Brand Name(s) Golden Natural Product Inc. Product Description: Product Description Dried Apricot FDA Announcement Golden Natural Products, Inc. of Brooklyn, NY…
FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) in combination with Lenvima (lenvatinib) for advanced endometrial carcinoma
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 a quick update on another recent FDA cancer drug approval. On July 21, 2021, the FDA approved pembrolizumab (brand name…
Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions
Philips Respironics has voluntarily recalled certain ventilators, BiPAP, and CPAP machines due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain…
Cahill’s Farm Cheese Recalls Specialty Cheddar Cheese Due to Possible Health Risk
Summary Company Announcement Date: July 29, 2021 FDA Publish Date: July 29, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential Listeria monocytogenes Company Name: Cahill’s Farm Cheese Brand Name: Brand Name(s) Cahill’s Farm Cheese Lidl Product Description: Product Description Cheddar Cheese Company Announcement Cahill’s Farm Cheese, Ireland is recalling a…
Sunshine Mills, Inc. Issues Voluntary Recall of Certain Products Due to Potentially Elevated Levels of Aflatoxin
Summary Company Announcement Date: July 29, 2021 FDA Publish Date: July 29, 2021 Product Type: Animal & VeterinaryFood & Beverages Pet Food Reason for Announcement: Recall Reason Description Elevated Levels of Aflatoxin Company Name: Sunshine Mills, Inc. Brand Name: Brand Name(s) Triumph, Evolve, Nature Farms, Elm and others Product Description: Product Description Company Announcement Sunshine…