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 Product Name: LifeSPARC System Product Model: LifeSPARC Controller, Model LS-1000 Distribution Dates: December 19, 2019 to present Devices Recalled in the U.S.: 484 Date Initiated by Firm:…
Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Atenolol 25 mg Tablets and Clopidogrel 75 mg Tablets Due to a Label Mix-up
Summary Company Announcement Date: September 29, 2022 FDA Publish Date: September 29, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Label Mix-up Company Name: Golden State Medical Supply, Incorporated Brand Name: Brand Name(s) Golden State Medical Supply, Incorporated Product Description: Product Description Clopidogrel 75mg Tablets, Atenolol 25mg Tablets Company Announcement FOR…
The Chai Box Announces Voluntary Recall of Chai Concentrate Mix and Chai Concentrate Unsweetened Mix Due to Potential Clostridium Botulinum Contamination
Summary Company Announcement Date: September 29, 2022 FDA Publish Date: September 29, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential under-processing which may lead to Clostridium botulinum contamination. Company Name: The Chai Box Brand Name: Brand Name(s) The Chai Box Product Description: Product Description CHAI CONCENTRATE MIX AND CHAI CONCENTRATE…
Nurse Sentenced to Prison for Tampering with Fentanyl Vials
Department of JusticeDistrict of Connecticut FOR IMMEDIATE RELEASEThursday, September 22, 2022 Vanessa Roberts Avery, United States Attorney for the District of Connecticut, announced that BRYAN WILSON, 40, of Madison, was sentenced today by U.S. District Judge Michael P. Shea in Hartford to 24 months of imprisonment, followed by three years of supervised release, for tampering with…
Proper Trade LLC/My Stellar Lifestyle Issues Voluntary Nationwide Recall of Wonder Pill Capsules Due to the Presence of Undeclared Tadalafil
Summary Company Announcement Date: September 27, 2022 FDA Publish Date: September 28, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains undeclared tadalafil Company Name: Proper Trade LLC/My Stellar Lifestyle Brand Name: Brand Name(s) My Stellar Lifestyle Product Description: Product Description Wonder Pill Capsules Company Announcement Proper Trade LLC/My Stellar Lifestyle is…
Momyer Distribution Inc. Issues Allergy Alert on Undeclared Milk in Dark Chocolate Almonds
Summary Company Announcement Date: September 28, 2022 FDA Publish Date: September 28, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Milk Company Name: Momyer Distribution Inc Brand Name: Brand Name(s) PRODUCE, Holly Hill Product Description: Product Description Dark Chocolate Almonds, 9.5 oz container Company Announcement Momyer Distribution Inc of Salem,…
FDA D.I.S.C.O. Burst Edition: FDA approvals of Imbruvica (ibrutinib) for pediatric patients with chronic graft versus host disease, and Pemazyre (pemigatinib) for adults with relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 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 August 24, 2022, the FDA approved ibrutinib (brand name…
A Fresh Take on What “Healthy” Means on Food Packages
With so many food options out there, it is helpful to have information on food packages that can empower you to identify healthier choices. The U.S. Food and Drug Administration is proposing to update its definition of “healthy.” That includes the nutritional criteria a product must meet to put the claim “healthy” on the package….
Eugia US LLC Issues Voluntary Nationwide Recall of Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), Due to the Presence of Particulate Matter
Summary Company Announcement Date: September 27, 2022 FDA Publish Date: September 27, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of a dark red, brown and black particulate inside the vial Company Name: Eugia US LLC Brand Name: Brand Name(s) Auromedics Product Description: Product Description Acyclovir Intravenous Product Company Announcement FOR IMMEDIATE…
Van Law Food Products Issues Allergy Alert on Undeclared Soy and Wheat in Product Expanded
Summary Company Announcement Date: September 23, 2022 FDA Publish Date: September 23, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Soy & Wheat Company Name: VanLaw Food Products Inc. Brand Name: Brand Name(s) Whole Foods Market 365 Product Description: Product Description Organic Creamy Caesar Dressing Company Announcement VanLaw Food Products…