Summary Company Announcement Date: March 16, 2023 FDA Publish Date: March 16, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Pine Nuts Company Name: BC Gourmet USA, Inc. Brand Name: Brand Name(s) Product Description: Product Description Pink pesto pasta sauce Company Announcement BC Gourmet USA, Inc. of Lynn, Massachusetts is…
California Splendor, Inc. Recalls Kirkland Brand Bags of Frozen Organic Whole Strawberries Distributed by Costco in Los Angeles, Hawaii, and in Two San Diego Business Centers Because of Possible Health Risk
Summary Company Announcement Date: March 16, 2023 FDA Publish Date: March 16, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Hepatitis A Company Name: California Splendor, Inc. Brand Name: Brand Name(s) Kirkland Signature Product Description: Product Description Frozen Organic Strawberries Company Announcement California Splendor, Inc. of San Diego, California is recalling…
Regional Recall: Clio Snacks Voluntarily Recalls Strawberry Granola & Greek Yogurt Parfait Bars from Select Walmart Stores Because of Possible Health Risk
Summary Company Announcement Date: March 14, 2023 FDA Publish Date: March 15, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Listeria monocytogenes Company Name: Clio Snacks Brand Name: Brand Name(s) Product Description: Product Description Strawberry Granola & Greek Yogurt Parfait Bar Company Announcement Clio Snacks of Piscataway, N.J. is voluntarily recalling…
Former CEO Of Medical Device Company Indicted For Creating And Selling A Fake Medical Component That Was Implanted Into Patients
Department of JusticeU.S. Attorney’s OfficeSouthern District of New York FOR IMMEDIATE RELEASEThursday, March 9, 2023 Medical Device Company Admitted Wrongdoing and Entered into Non-Prosecution Agreement Requiring $10 Million Monetary Penalty and Ongoing Compliance Measures Damian Williams, the United States Attorney for the Southern District of New York, Michael J. Driscoll, the Assistant Director in Charge…
Baxter Issues Urgent Medical Device Correction for LIFE2000 Ventilation System Due to Potential for Patient Desaturation When Connected with an Oxygen Concentrator
Summary Company Announcement Date: March 10, 2023 FDA Publish Date: March 10, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential for patient oxygen desaturation (low blood oxygen) events that can occur under certain conditions when the Life2000 system is connected with a third-party oxygen concentrator Company Name: Baxter International Inc. Brand…
UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants – FDA Safety Communication
Date Issued: March 8, 2023 The U.S. Food and Drug Administration (FDA) is providing an update on reports of squamous cell carcinoma (SCC) in the scar tissue (capsule) that forms around breast implants. Previously, on September 8, 2022, the FDA released a safety communication informing the public of reports of cancers, including SCC and various…
FDA D.I.S.C.O. Burst Edition: FDA approval of Jemperli (dostarlimab-gxly) for dMMR endometrial cancer
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 a recent FDA cancer drug approval. On February 9, 2023, the FDA approved dostarlimab-gxly (brand name…
Update: Potential Risk of Exposure to Toxic Compounds When Using Hemodialysis and Peritoneal Dialysis Systems – Letter to Health Care Providers
March 7, 2023 The U.S. Food and Drug Administration (FDA) is continuing to evaluate the potential risk of exposure to toxic compounds when using dialysis systems. On May 6, 2022, the FDA issued a Letter to Health Care Providers about the evaluation of the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs)…
Pharmedica USA LLC Issues Voluntary Worldwide Recall of Purely Soothing 15% MSM Drops Due to Non-Sterility
Summary Company Announcement Date: March 03, 2023 FDA Publish Date: March 03, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Non-sterility Company Name: Pharmedica USA LLC Brand Name: Brand Name(s) Purely Soothing Product Description: Product Description 15% MSM Drops Company Announcement Phoenix, Arizona, USA; Pharmedica USA LLC is voluntarily recalling two lots of…
All Allergenic Extracts for Diagnosis of Food Allergy: FDA Safety Communication – FDA Requires Warning about Anaphylaxis Following False Negative Food Allergen Skin Test Results in the Prescribing Information
[Posted 03/03/2023] AUDIENCE: Allergy and Immunology, Pediatrics, Health Professional, Patient ISSUE: In 2022, during safety monitoring of FDA Adverse Event Reporting System (FAERS) data, FDA became aware of increased postmarketing adverse event reporting of false negative skin test results with certain lots of ALK-Abello’s Allergenic Extract – Peanut (Arachis hypogaea) – For Diagnostic Use Only. Some of these reports of…