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 October 24, 2023, the FDA approved ivosidenib (brand name…
Do Not Use Cardinal Health Monoject Syringes with Syringe Pumps and PCA Pumps
November 20, 2023 The U.S. Food and Drug Administration (FDA) is alerting health care providers and facilities not to use Cardinal Health Monoject syringes with syringe pumps and patient-controlled analgesia (PCA) pumps while the FDA further evaluates this issue. In June 2023, Cardinal Health began distributing Monoject syringes branded as “Cardinal Health” Monoject syringes. These…
Kilitch Healthcare India Limited Issues Voluntary Nationwide Recall of Various Eye Drops for Potential Safety Reasons
Summary Company Announcement Date: November 15, 2023 FDA Publish Date: November 15, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety Potential Safety Concerns Company Name: Kilitch Healthcare India Limited Brand Name: Brand Name(s) Multiple brands Product Description: Product Description Lubricant Eye Drops & Multi-Symptom Eye Drops Company Announcement FOR…
KinderFarms, LLC Voluntarily Recalling all KinderMed Pain & Fever Products Due to Acetaminophen Instability
Summary Company Announcement Date: November 13, 2023 FDA Publish Date: November 17, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Acetaminophen Instability Company Name: KinderFarms, LLC Brand Name: Brand Name(s) Product Description: Product Description OTC Pain and Fever Reliever for Infants and Kids Company Announcement FOR IMMEDIATE RELEASE – November 13,…
HMC Farms Voluntarily Recalls Whole Peaches, Plums and Nectarines Sold at Retail Stores in 2022 and 2023 Because of Possible Health Risk
Summary Company Announcement Date: November 17, 2023 FDA Publish Date: November 17, 2023 Product Type: Food & Beverages Fruit/Fruit Product Foodborne Illness Reason for Announcement: Recall Reason Description Potential to be contaminated with Listeria monocytogenes Company Name: The HMC Group Marketing, Inc. Brand Name: Brand Name(s) Multiple brands Product Description: Product Description Whole Peaches, Plums,…
Wilcox Ice Cream Recalls Multiple Ice Cream Products Because of Possible Health Risk
Summary Company Announcement Date: November 18, 2023 FDA Publish Date: November 18, 2023 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential to be contaminated with Listeria monocytogenes Company Name: Wilcox Ice Cream Brand Name: Brand Name(s) Multiple brands Product Description: Product Description Ice Cream, Yogurt, Ice Cream Bars and…
B. Braun Medical, Inc. Recalls Infusomat® Space® Large Volume Pump, Wireless and Infusomat® Space® Large Volume Pump, Non-Wireless BATTERY PACK Due to Faulty Occlusion Alarm
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. Please be aware, this recall is a correction, not a product removal. Recalled Product Device Use The Infusomat® Space Volumetric Infusion Pump System, which includes the Infusomat Space…
TFP Nutrition Expands Voluntary Recall of Dry Dog, Dry Cat, and Catfish Food Due to Potential Salmonella Health Risk. Recall Includes Dry Dog, Dry Cat, and Catfish Foods Manufactured in Nacogdoches, TX Facility
Summary Company Announcement Date: November 16, 2023 FDA Publish Date: November 16, 2023 Product Type: Animal & VeterinaryFood & Beverages Pet Food Foodborne Illness Reason for Announcement: Recall Reason Description Potential Salmonella contamination Company Name: TFP Nutrition Brand Name: Brand Name(s) Multiple brands Product Description: Product Description Dry Dog, Dry Cat, and Catfish Food Company…
Operator of Central California Bio-Lab Indicted for Distributing Adulterated and Misbranded COVID-19 Tests and Lying to Authorities
Department of JusticeU.S. Attorney’s OfficeEastern District of California FOR IMMEDIATE RELEASEThursday, November 16, 2023 FRESNO, Calif. — A federal grand jury returned a three-count indictment today against Jia Bei Zhu, aka Jesse Zhu, Qiang He, and David He, 62, a citizen of China who formerly resided in Clovis, charging him with distributing adulterated and misbranded…
Asensus Surgical Inc. Recalls Senhance Surgical System Due to Malfunctions with Unintended Movement of the Robotically-Assisted Surgical Device
Please be aware, this recall is a correction, not a product removal. 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 (Include the following information) Product Names: Asensus Senhance Surgical System Product Codes: See Recall Database…