Summary Company Announcement Date: January 28, 2022 FDA Publish Date: January 31, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Tadalafil Company Name: Esupplementsales, LLC Brand Name: Brand Name(s) Product Description: Product Description Hard Dawn Rise and Shine capsules Company Announcement FOR IMMEDIATE RELEASE – 01/28/2022 – Orangevale, CA, Esupplementsales, LLC is…
AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Polymyxin B for Injection USP, 500,000 Unit per Vial, Due to the Presence of Particulate Matter
Summary Company Announcement Date: January 26, 2022 FDA Publish Date: January 28, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Particulate Matter Company Name: AuroMedics Pharma LLC Brand Name: Brand Name(s) Auromedics Product Description: Product Description Polymyxin B for Injection USP, 500,000 Units/Vial Company Announcement FOR IMMEDIATE RELEASE – January 26,…
Stop Using Empowered Diagnostics COVID-19 Tests: FDA Safety Communication
Date Issued: January 28, 2022 The U.S. Food and Drug Administration (FDA) is warning people to stop using the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. These tests were distributed with labeling indicating they are authorized by the FDA, but neither test has been authorized, cleared, or approved…
Empowered Diagnostics Recalls COVID-19 Tests due to Risk of False Results
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious adverse health consequences or death. Recalled Product Empowered Diagnostics, LLC CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test All lot codes Distribution Dates: January 1, 2021 to November…
Blaine Labs Issues Voluntary Nationwide Recall of RevitaDerm Wound Care Gel Due to Bacterial Contamination
Summary Company Announcement Date: January 27, 2022 FDA Publish Date: January 27, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description May be contaminated with Bacillus cereus Company Name: Blaine Labs Company Brand Name: Brand Name(s) RevitaDerm Product Description: Product Description Wound Care Gel Company Announcement SANTA FE SPRINGS, Calif., Jan. 27, 2022 —…
Philips Respironics Recalls Certain Trilogy EVO Ventilators for Potential Health Risks from PE-PUR Foam
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: Trilogy Evo ventilator Repair kits for Trilogy Evo muffler assembly* Model Numbers: Manufacturing Dates: April 15, 2021 to May 24, 2021 Distribution Dates: April 15,…
Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Recall of One Batch of Semglee® (insulin glargine injection), 100 units/mL (U-100), 3 mL Prefilled Pens, Due to the Potential for a Missing Label in the Batch
Summary Company Announcement Date: January 18, 2022 FDA Publish Date: January 19, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Missing Label Company Name: Mylan Pharmaceutical Inc. Brand Name: Brand Name(s) Product Description: Product Description Insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens Company Announcement PITTSBURGH – Jan. 18, 2022 – Mylan…
Medtronic Inc. Recalls HawkOne Directional Atherectomy System Due to Risk of Tip Damage During Use
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 HawkOne Directional Atherectomy System Product Codes and Lot Numbers: See Recall Database Entry Devices Recalled in the United States: 95,110 Distribution Date: January 22, 2018 to October…
UPDATE: Blood Specimen Collection Tube Conservation Strategies – Letter to Health Care and Laboratory Personnel
January 19, 2022 The U.S. Food and Drug Administration (FDA) is aware the United States is experiencing significant interruptions in the supply of several blood specimen collection (blood draw) tubes because of an increase in demand during the COVID-19 public health emergency and recent vendor supply challenges. The FDA is expanding the medical device shortage…
Getinge USA Sales, LLC Recalls the Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems Due to a Risk of Harmful Chemical Exposure
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: Vaporizer Sevoflurane, Maquet Filling for Flow Family Anesthesia Systems Model Number: Model 6886601 Manufacturing Dates: December 15, 2020 to July 21, 2021 Distribution Dates: February…