BEUDAMED
    FDA Enforcement Class II Terminated

    Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTION***", Net. Wt. 4 fl. oz./118mL, Catalog No. NSP-04 The product is a topical spray used to treat discomfort and other pathological conditions affecting exposed soft tissues of the body caused by microbial infections.

    Recall: Z-1627-2018 · Reported May 9, 2018

    Enforcement

    Recall Number
    Z-1627-2018
    Event ID
    79962
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Conseal International, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 9, 2018
    Initiation Date
    April 25, 2018
    Classification Date
    May 3, 2018
    Termination Date
    April 2, 2019
    Address
    90 Kerry Place, Suite 2, Norwood, MA, 02062-4765, United States

    Description

    Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTION***", Net. Wt. 4 fl. oz./118mL, Catalog No. NSP-04 The product is a topical spray used to treat discomfort and other pathological conditions affecting exposed soft tissues of the body caused by microbial infections.

    Reason

    A recent FDA inspection of the firm revealed significant Current Good Manufacturing Practices (cGMP) deficiencies including lack of data to support products conform to final specifications, and lack of expiration dates on the product being recalled.

    Code Info

    Product does not bear lot codes. All product lacking lot codes and expiration dates is being recalled.

    Distribution

    US Distribution to the states of : AL, MS, and MA.

    Quantity

    384