BEUDAMED
    FDA Enforcement Class II Terminated

    PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4 For Inhalation Only Rx Product Usage: The contents of these vials are used in conjunction with a nebulizer for the induction of sputum production where sputum production is indicated.

    Recall: Z-0795-2016 · Reported February 17, 2016

    Enforcement

    Recall Number
    Z-0795-2016
    Event ID
    73053
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pharmacaribe llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 17, 2016
    Initiation Date
    December 29, 2015
    Classification Date
    February 10, 2016
    Termination Date
    March 28, 2017
    Address
    3513 Dileuca St, N/A, Punta Gorda, FL, 33950-7835, United States

    Description

    PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4 For Inhalation Only Rx Product Usage: The contents of these vials are used in conjunction with a nebulizer for the induction of sputum production where sputum production is indicated.

    Reason

    Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+)

    Code Info

    Lot # CIY Exp.Date August 2017 UPC Number: 030915339988 (on the box of 60 vials) UPC Number: 10030915339985 (on the shipping case of 12 boxes)

    Distribution

    US Nationwide Distribution in the states of FL, LA, TX and VA

    Quantity

    7,020 vials