October 7, 2020 The U.S. Food and Drug Administration (FDA) recommends that health care providers give clear, step-by-step instructions to patients who, in a health care setting, are self-collecting anterior nares (nasal) samples for SARS-CoV-2 testing. Without proper instructions, patients may not collect an adequate sample for testing, which may decrease the sensitivity of the…
Marksans Pharma Limited Issues Expansion of Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg & 750mg, Due to the Detection of N-Nitrosodimethylamine (NDMA)
Summary Company Announcement Date: October 02, 2020 FDA Publish Date: October 05, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity Company Name: Marksans Pharma Limited Brand Name: Brand Name(s) Time-Cap Labs Inc. Product Description: Product Description Metformin Hydrochloride for Extended-Release Tablets, USP 500 mg and…
Ashtel Studios Issues Voluntary Recall of Licensed Hand Sanitizers Packaged in 0.84 Fluid Ounce Pouches Due to Misbranding Because They Resemble Food and Drink Container Pouches
Summary Company Announcement Date: October 01, 2020 FDA Publish Date: October 02, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Product is packaged in containers resembling a food and drink pouch Company Name: Ashtel Studios Brand Name: Brand Name(s) Smart Care Product Description: Product Description Hand sanitizer packaged in 0.84 oz. pouches Company…
Becton Dickinson CareFusion 303, Inc. Recalls Alaris™ System Pump Module and Pump Module Door Assembly Replacement Kits Due to the Potential for Stuck or Unresponsive Keys
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 BD Alaris Pump Module and Pump Module Door Assembly Replacement Kits Affected Models: Model 8100 (Pump Module) Pump Module Door Assembly Replacement Kits, Part Numbers: 49000346 49000239…
Potential Risk of Infection during Cardiac Surgery When Using the CardioQuip Modular Cooler-Heater Device – Letter to Health Care Providers
The U.S. Food and Drug Administration (FDA) continues to monitor the risk of Nontuberculous mycobacteria (NTM) infections in patients who have undergone cardiothoracic surgery using heater-cooler devices, and to collaborate with stakeholders including public health partners, manufacturers, and experts to evaluate additional strategies to reduce the risk of infection from using these devices during cardiac…
DMM VISSION, S.A. DE C.V. Issues Voluntary Nationwide Recall of Cleaner Hand Sanitizer 500 mL and 1200 mL Bottles Due to the Possible Presence of Undeclared Methanol (Wood Alcohol)
Summary Company Announcement Date: September 08, 2020 FDA Publish Date: September 30, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Presence of Methanol (Wood Alcohol) Company Name: Estado de México, México, DMM VISSION, S.A. de C.V Brand Name: Brand Name(s) Product Description: Product Description Cleaner Hand Sanitizer Company Announcement Estado de México,…
Benzodiazepine Drug Class: Drug Safety Communication – Boxed Warning Updated to Improve Safe Use
TOPIC: Benzodiazepine Drug Class: Drug Safety Communication – Boxed Warning Updated to Improve Safe Use AUDIENCE: Patient, Health Professional, Pharmacy ISSUE: The FDA is requiring the Boxed Warning, FDA’s most prominent warning, be updated by adding other information to the prescribing information for all benzodiazepine medicines. This information will describe the risks of abuse, misuse, addiction,…
Benadryl (diphenhydramine): Drug Safety Communication – Serious Problems with High Doses of the Allergy Medicine
TOPIC: Benadryl (diphenhydramine): Drug Safety Communication – Serious Problems with High Doses of the Allergy Medicine AUDIENCE: Consumer, Patient, Health Professional, Pharmacy ISSUE: FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) allergy medicine Benadryl (diphenhydramine) can lead to serious heart problems, seizures, coma, or even death. FDA is aware of…
Mammography Problems at Allison Breast Center at Monument Radiology in Richmond, Virginia: FDA Safety Communication
Date Issued: September 25, 2020 The U.S. Food and Drug Administration (FDA) is alerting patients who had mammograms at Allison Breast Center at Monument Radiology, located in Richmond, Virginia, on or after June 17, 2018, about possible problems with the quality of their mammograms. Recommendations for Patients If you have had a more recent mammogram…
Recommendations About the Use of Dental Amalgam in Certain High-Risk Populations: FDA Safety Communication
Date Issued: September 24, 2020 The U.S. Food and Drug Administration (FDA) is providing recommendations about the use of dental amalgam in certain groups of people who may be at greater risk to the potential adverse health effects of mercury exposure, to include: Pregnant women and their developing fetuses; Women who are planning to become…