- Sunstar Americas Inc. Issues Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contaminationby FDA on October 28, 2020 at 4:00 am
Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 6/30/22 – 9/30/22 (see specific lots below) to the consumer level. This product may be contaminated with the bacteria Burkholderia lata.
- Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Drug Safety Communication - Avoid Use of NSAIDs in Pregnancy at 20 Weeks or Laterby FDA on October 15, 2020 at 9:00 pm
FDA is warning that use of NSAIDs around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby. This can lead to low levels of amniotic fluid surrounding the baby and possible complications.
- Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection - Letter to Health Care Providersby FDA on October 15, 2020 at 4:00 am
The FDA is concerned that certain respirators from China may not provide adequate protection to health care personnel based on testing by CDC NIOSH.
- Recommendations on Providing Clear Instructions to Patients Who Self-Collect an Anterior Nares (Nasal) Sample in a Health Care Setting for SARS-CoV-2 Testing - Letter to Health Care Providersby FDA on October 7, 2020 at 4:00 am
FDA's recommendations to health care providers on giving instructions to patients who self-collect an anterior nares sample for SARS-CoV-2 testing.
- 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)by FDA on October 5, 2020 at 4:00 am
Marksans Pharma Limited, India is voluntarily expanding its earlier initiated recall on June 05, 2020 to include an additional 76 unexpired lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, & 750mg to the consumer level. Marksans performed N-Nitrosodimethylamine (NDMA) testing of
- 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 Pouchesby FDA on October 2, 2020 at 4:00 am
Ashtel Studios has announced a voluntary recall of all lots of licensed hand sanitizer packaged in .84 oz containers resembling food and drink pouches labeled with various children’s characters listed in the table below to the consumer level. The products are being recalled because they are packaged
- 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 Keysby FDA on October 2, 2020 at 4:00 am
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
- 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)by FDA on September 30, 2020 at 4:00 am
Estado de México, México, DMM VISSION, S.A. de C.V. is voluntarily recalling five lots of Cleaner Hand Sanitizer, 500 mL and 1,200 mL plastic clear bottles with white tops currently in US distribution to the consumer level. This recall is being initiated out of abundance of caution due to detection
- Potential Risk of Infection during Cardiac Surgery When Using the CardioQuip Modular Cooler-Heater Device – Letter to Health Care Providersby FDA on September 30, 2020 at 4:00 am
The FDA is providing new information about the risk of NTM infections in patients who have undergone cardiothoracic surgeries using heater-cooler devices.
- Mammography Problems at Allison Breast Center at Monument Radiology in Richmond, Virginia: FDA Safety Communicationby FDA on September 25, 2020 at 4:00 am
Mammography Problems at Allison Breast Center at Monument Radiology
- 2020 Safety Communicationsby FDA on September 25, 2020 at 4:00 am
The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.
- Benadryl (diphenhydramine): Drug Safety Communication - Serious Problems with High Doses of the Allergy Medicineby FDA on September 24, 2020 at 1:19 pm
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.
- Recommendations About the Use of Dental Amalgam in Certain High-Risk Populations: FDA Safety Communicationby FDA on September 24, 2020 at 4:00 am
The FDA is providing recommendations for certain high-risk populations may be more vulnerable to potential adverse health effects of mercury exposure from dental amalgam.
- Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of RIOMET ER™ (Metformin Hydrochloride for Extended-Release Oral Suspension) Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limitby FDA on September 23, 2020 at 4:00 am
Sun Pharmaceutical Industries, Inc. (SUN PHARMA), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. is voluntarily recalling one lot of RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the consumer level. The reason for the recall is due to
- Benzodiazepine Drug Class: Drug Safety Communication - Boxed Warning Updated to Improve Safe Useby FDA on September 23, 2020 at 4:00 am
The FDA is requiring the Boxed 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, physical dependence, and withdrawal reactions across all the medicines in the class.
- BD Announces FDA Classifications for August 4th Recalls of BD Alaris™ System Hardware for Keypads, Incorrect Module Types and/or Sizes, and Channel Errorby FDA on September 21, 2020 at 4:00 am
Three of the recalls, which BD announced on Aug. 4, 2020, have been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means that FDA has determined that there is a reasonable probability that the use of the product will cause serious adverse health consequences or d
- Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid®, Thyroid Tablets, USP Due to Sub Potencyby FDA on September 17, 2020 at 4:00 am
Acella Pharmaceuticals, LLC is voluntarily recalling one lot of 15-mg and one lot of 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because testing has found these lots to be sub potent. The product may have
- 2020 Medical Device Recallsby FDA on September 16, 2020 at 1:00 pm
List of Medical Device recalls in 2020.
- Becton Dickinson (BD) CareFusion 303 Inc. Recalls Alaris™ Syringe and Alaris™ PCA Modules Due to Potential Incorrect Display of Syringe Types and/or Sizesby FDA on September 16, 2020 at 4:00 am
The Alaris System is an infusion system. If parts of the PCA or Syringe Modules are damaged, incorrect syringe details may show, leading to inaccurate infusions.
- Becton Dickinson (BD) CareFusion 303 Recalls Alaris System Infusion Pumps Due to Damaged Inter-Unit Interface Connectors, Loose or Missing Battery Screws and A Broken Upper and Lower Hinge Posts and Membrane Frameby FDA on September 14, 2020 at 4:00 am
The Alaris System Infusion Pump is the foundation of the infusion system. Multiple models are being recalled due to damaged IUI Connectors, loose or missing Battery Screws and broken upper and lower hinge posts and membrane frame.