1. 2020 Medical Device Recalls

    List of Medical Device recalls in 2020.
  2. Transliquid Technologies LLC Issues Voluntary Recall of Mystic Shield Protection Topical Solution Due to Presence of Undeclared Methanol for the States of California, Louisiana, Massachusetts, and Texas

    Transliquid Technologies LLC is voluntarily recalling all Mystic Shield Protection Topical Solution, manufactured by Mystic Intl S.A. de C.V in Mexico City, and packaged in an 8.45 ounce (250 ml) bottles, to the consumer level.
  3. Arrow International Inc. Recalls Arrow AutoCAT®2 and AC3 Optimus® IABP Series Due to Possible Breakdown of Motor Connector Wires

    Arrow International is recalling the pumps because both devices have a part that may break, char, and discolor the motor connector wires.
  4. UVT, INC. Issues Voluntary Nationwide Recall of SANIDERM ADVANCED HAND SANITIZER Due to the Potential Presence of Undeclared Methanol (Wood Alcohol)

    UVT, INC. is voluntarily recalling 38,830 liters of SANIDERM ADVANCED HAND SANITIZER, packaged in 1-liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol)
  5. Saniderm Products Voluntarily Issues Regional (Virginia, Maryland, New Jersey) Recall of 1 L Saniderm Advanced Hand Sanitizer bottles produced by Eskbiochem SA de CV Due to the Potential Presence of Undeclared Methanol (Wood Alcohol)

    Saniderm Products (Saniderm) is voluntarily recalling Saniderm Advanced Hand Sanitizer, packaged in 1-liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). In response to a recent news alert by the Food and Drug Administration
  6. Chengdu Ai Qin E-Commerce Co., Ltd Issues Nationwide Recall of TTDEYE Brand Colored Contact Lenses

    On June 18, 2020, Chengdu Ai Qin E-commerce Co., Ltd initiated a nationwide recall of 1362 pairs of colored contact lenses. The relevant series of contact lenses have been found to be distributed without FDA clearance and may pose a threat to health.
  7. Certain COVID-19 Serology/Antibody Tests Should Not Be Used - Letter to Clinical Laboratory Staff and Health Care Providers

    FDA warns lab staff and health care providers about using certain COVID-19 Serology/Antibody Tests.
  8. GSK Consumer Healthcare Issues Voluntary Nationwide Recall of Children's Robitussin® Honey Cough and Chest Congestion DM and Children's Dimetapp® Cold and Cough Due to Dosing Cups Missing Some Graduation Markings

    GSK Consumer Healthcare is voluntarily recalling to the retail level two lots (listed below) of Children’s Robitussin® Honey Cough and Chest Congestion DM and one lot of Children’s Dimetapp® Cold and Cough, due to the inclusion of incorrect dosing cups.
  9. Remdesivir by Gilead Sciences: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of Treatment

    FDA is warning health care providers that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir.
  10. Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of One Lot of Metformin Hydrochloride Extended-Release Tablets USP, 500mg Due to the Detection of N-Nitrosodimethylamine (NDMA)

    Lupin Pharmaceuticals Inc. is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets USP (generic equivalent of Fortamet®), 500mg, lot G901203 to the consumer level. FDA analysis revealed that this lot exceeded the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine

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