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 November 8, 2023, the FDA approved fruquintinib (brand name…
Getinge / Atrium Medical Corporation Issues Medical Device Correction for Nurse Assist Syringes Provided with Express Drains
Summary Company Announcement Date: January 03, 2024 FDA Publish Date: January 04, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Syringes provided with Express Drains could not be verified to be sterile. Company Name: Getinge/Atrium Medical Corporation Brand Name: Brand Name(s) Product Description: Product Description Express Drains Company Announcement On December 13,…
Urgent Voluntary Recall of D&D Commodities Ltd. 3-D Pet Products Premium Parrot Food Due to Potential Salmonella Contamination
Summary Company Announcement Date: January 04, 2024 FDA Publish Date: January 05, 2024 Product Type: Animal & VeterinaryFood & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Due to potential Salmonella contamination Company Name: D&D Commodities, Ltd. Brand Name: Brand Name(s) 3-D Pet Products Product Description: Product Description Parrot Food Company Announcement Greeley, CO…
TOYOU SNACKS Issues Allergy Alert On ToYou Snacks Snack Bars Due to Undeclared Soy
Summary Company Announcement Date: January 05, 2024 FDA Publish Date: January 05, 2024 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Due to Undeclared Soy Company Name: ToYou Snacks Brand Name: Brand Name(s) Product Description: Product Description Snack Bars in a variety of flavors Company Announcement ToYou Snacks, of Winter Garden,…
FDA D.I.S.C.O. Burst Edition: FDA approval of Augtyro (repotrectinib) for locally advanced or metastatic ROS1-positive non-small cell lung 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 November 15, 2023, the FDA approved repotrectinib (brand name…
Do Not Use Synovo Total Hip Resurfacing System: FDA Safety Communication
Date Issued: January 3, 2024 The U.S. Food and Drug Administration (FDA) is providing recommendations for health care providers considering using the Total Hip System, including resurfacing implants, manufactured by Synovo Production, Inc. (Synovo) and for patients who may have received certain implants used in the Synovo Total Hip System after 2019. Three components of…
Win Luck贸易公司对干梅子中未申报的亚硫酸盐发出过敏警报
Summary Company Announcement Date: January 03, 2024 FDA Publish Date: January 04, 2024 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description May contain undeclared sulfites. Company Name: Win Luck Trading, Inc. Brand Name: Brand Name(s) Tasty Snacks Product Description: Product Description Dried Plums Company Announcement 位于新泽西州巴约讷的Win Luck贸易公司正在召回其“梅子女王”干梅子，因为它们可能含有未申报的亚硫酸盐。对亚硫酸盐过敏的人如果食用该产品，会有严重或危及生命的过敏反应的风险。 被召回的“梅子女王”干梅子在纽约和新泽西的零售店销售。 召回的产品包装在一个200克的透明塑料容器中。品牌名称为“味良之果”。 到目前为止还没有与这个问题有关的疾病报告。 此次召回是在纽约州农业和市场部例行抽样发现该产品中含有亚硫酸盐后发起的，该产品的包装并未显示亚硫酸盐的存在。随后的调查表明，问题是由公司生产和包装过程的暂时故障引起的。…
Win Luck Trading Inc. Issues Allergy Alert on Undeclared Sulfites in Dried Plums
Summary Company Announcement Date: January 03, 2024 FDA Publish Date: January 04, 2024 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description May contain undeclared sulfites Company Name: Win Luck Trading, Inc. Brand Name: Brand Name(s) Tasty Snacks Product Description: Product Description Dried Plums Company Announcement Win Luck Trading Inc. of Bayonne,…
2024 Safety Communications
The FDA posts Medical Device Safety Communications to describe the FDA’s current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management. 2024 Safety Communications Content current as of: 01/03/2024 Article source: http://www.fda.gov/medical-devices/safety-communications/2024-safety-communications
ForeverMen contains hidden drug ingredient
[1-2-2024] The Food and Drug Administration is advising consumers not to purchase or use ForeverMen, a product promoted and sold as an energy booster on various websites, including www.amazon.com, and possibly in some retail stores. FDA laboratory analysis confirmed that ForeverMen contains sildenafil, the active ingredient in the FDA-approved prescription drug Viagra, used to treat…