Summary Company Announcement Date: November 17, 2023 FDA Publish Date: November 21, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination identified as Penicillium brevicompactum Company Name: Bayer Brand Name: Brand Name(s) Product Description: Product Description Vitrakvi® (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottles Company Announcement FOR IMMEDIATE RELEASE –…
Voluntary Recall of SoClean Equipment Intended for Use with CPAP Devices and Accessories: FDA Safety Communication
Date Issued: November 21, 2023 The U.S. Food and Drug Administration (FDA) is providing additional information about a product recall related to the use of SoClean2 and SoClean3 equipment used to clean, sanitize, or disinfect CPAP devices and accessories. The company’s recall consists of a new User Manual with additional instructions for use and a…
Noah’s Wholesale, LLC Issues Voluntary Nationwide Recall of the Rock Due to Presence of Undeclared Sildenafil
Summary Company Announcement Date: October 18, 2023 FDA Publish Date: November 21, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared drug, Sildenafil Company Name: Noah’s Wholesale, LLC Brand Name: Brand Name(s) Noah’s Wholesale, LLC Product Description: Product Description Dietary Supplement with undeclared Sildenafil Company Announcement FOR IMMEDIATE RELEASE – October 18, 2023…
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,…
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…
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…
Fresenius Medical Care Recalls Sanxin Single Use Syringes for Leakages
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 Names: Sanxin Single Use Sterile Syringes Product Codes and Part Numbers: Distribution Dates: April 30, 2021 to August 7, 2023 Devices Recalled in the U.S.: 12,477,300…
Baxter Healthcare Corporation Recalls Novum IQ Syringe Pump for Potential Underdosing
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 Product Names: Novum IQ Syringe Pump Product Codes: All Serial Numbers – See Recall Database Entry…