1. Boston Scientific Announces LOTUS Edge™ Aortic Valve System Voluntary Recall and Product Discontinuation

    Boston Scientific Corporation (NYSE: BSX) has announced it has initiated a global, voluntary recall of all unused inventory of the LOTUS Edge™ Aortic Valve System due to complexities associated with the product delivery system. The voluntary recall is related solely to the delivery system, as the va
  2. Genetic Variants of SARS-CoV-2 May Lead to False Negative Results with Molecular Tests for Detection of SARS-CoV-2 - Letter to Clinical Laboratory Staff and Health Care Providers

    Laboratories should expect some false negative results because the SARS-CoV-2 virus can mutate over time and not be detected.
  3. Fresenius Kabi Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter

    Fresenius Kabi USA is voluntarily recalling a single lot of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter. Particulate matter was found in reserve sample vials. No adverse event reports have been received
  4. Wear Face Masks with No Metal During MRI Exams: FDA Safety Communication

    The FDA is informing of a potential for injury during MRI while wearing a face mask that contains metal (such as surgical or non-surgical masks and respirators).
  5. Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19: FDA Safety Communication

    This Safety Communication describes the risk of false results, particularly false negative results, with the Curative SARS-Cov-2 test. Recommendations for patients, caregivers and health care professionals are provided.
  6. Essaar Inc. Issues Voluntary Nationwide Recall of Rubbing Alcohol Contaminated with Methanol

    Essaar Inc. is voluntarily recalling lot 200528303 of Soho Fresh 70% Rubbing Alcohol in 33.81 oz. clear plastic bottles to the consumer level. FDA analysis of the product revealed it is contaminated with methanol. Substantial methanol exposure can result in nausea, vomiting, headache, blurred visio
  7. Nostrum Laboratories, Inc. Expands Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

    Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) have been found to con
  8. 2021 Safety Communications

    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.
  9. Precision Dose, Inc. Issues Voluntary Nationwide Recall of Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Due to Microbial Contamination

    Precision Dose, Inc. is voluntarily recalling all lots of Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Unit Dose Cups bearing an expiration date from 1/31/2021 – 02/28/2022 (see specific lots below) to the consumer level
  10. UPDATE: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate: FDA Safety Communication

    This update to the February 2020 safety communication provides information on the final guidance, Product Labeling for Laparoscopic Power Morcellators.

Bristol

Monday-Friday: 9am - 6pm
Saturday: Closed
Sunday: Closed
Phone: 802.453.2999
Fax: 802.453.4006

Middlebury

Monday-Friday: 9am - 6pm
Saturday: 9am - 3pm
Sunday: 10am - 2pm
Phone: 802.388.3784
Fax: 802.388.1720

Vergennes

Monday-Friday: 9am - 6pm
Saturday: 9am - 1pm
Sunday: Closed
Phone: 802.877.1190
Fax: 802.877.1197