1. Baxter Issues Urgent Device Correction to Reinforce Important Safety Information Regarding Cleaning Practices of all Sigma Spectrum Infusion Pumps (V6, V8 and IQ)

    Baxter International Inc. announced today it has issued an Urgent Device Correction to reinforce important safety information regarding cleaning practices of all Spectrum infusion pumps distributed in the United States, Canada, and the Caribbean, as deviations from the specified cleaning methods may
  2. Sunstar Americas Inc. Issues Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

    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.
  3. Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Drug Safety Communication - Avoid Use of NSAIDs in Pregnancy at 20 Weeks or Later

    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.
  4. Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection - Letter to Health Care Providers

    The FDA is concerned that certain respirators from China may not provide adequate protection to health care personnel based on testing by CDC NIOSH.
  5. 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 Providers

    FDA's recommendations to health care providers on giving instructions to patients who self-collect an anterior nares sample for SARS-CoV-2 testing.
  6. 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)

    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
  7. 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

    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
  8. 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

    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
  9. 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)

    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
  10. Potential Risk of Infection during Cardiac Surgery When Using the CardioQuip Modular Cooler-Heater Device – Letter to Health Care Providers

    The FDA is providing new information about the risk of NTM infections in patients who have undergone cardiothoracic surgeries using heater-cooler devices.

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