Summary Company Announcement Date: October 24, 2022 FDA Publish Date: October 25, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril Company Name: Aurobindo Pharma USA, Inc. Brand Name: Brand Name(s) Aurobindo Pharma USA, Inc. Product Description: Product Description Quinapril and Hydrochlorothiazide Tablets…
Baxter Issues Urgent Medical Device Correction Regarding Potential Radio Frequency Interference With Other Devices Near Beds Installed With WatchCare System
Summary Company Announcement Date: October 21, 2022 FDA Publish Date: October 24, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential for radio frequency (RF) interference with other medical devices. Company Name: Baxter International Inc. Brand Name: Brand Name(s) Product Description: Product Description Incontinence management system Company Announcement Baxter International Inc. announced…
Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices
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: Amara View Full Face Mask DreamWisp Nasal Mask DreamWear Full Face Mask Wisp and Wisp Youth Nasal Mask Therapy Mask 3100 NC/SP Serial and Model…
Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton Due to Vial Breakage
Summary Company Announcement Date: October 12, 2022 FDA Publish Date: October 13, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Vial Breakage Company Name: Exela Pharma Sciences, LLC Brand Name: Brand Name(s) Exela & Civica Product Description: Product Description Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial Company Announcement FOR IMMEDIATE RELEASE…
Jiangsu Well Biotech Co., Ltd. Recalls COVID-19 Ag Rapid Test Devices That Are Not Authorized, Cleared, or Approved by the FDA
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: COVID-19 Ag Rapid Test Device Product Codes: See Recall Database Entry Distribution Dates: July 23, 2021 to January 23, 2022 Devices Recalled in the U.S.:…
LivaNova (TandemLife) Recalls LifeSPARC System for Risk of Unintentional Extended Pump Stop During Controller Critical Failure
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…
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…
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…
Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern
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: Philips Respironics BiPAP A30, A40, V30, and OmniLab Advanced+ Product Models: A-Series BiPAP A30 (Ventilator) A-Series BiPAP A40 (Ventilator) A-Series BiPAP V30 (Auto Ventilator) OmniLab…