BEUDAMED
    FDA Enforcement Class II Terminated

    Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz.. RX only, Professional Sample, Not for Sale. Pre-printed tube: MS31071, Shelf carton: PL51091-08 Atrapro Antipruritic HydroGel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis and atopic dermatitis.

    Recall: Z-0890-2013 · Reported March 6, 2013

    Enforcement

    Recall Number
    Z-0890-2013
    Event ID
    64316
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Oculus Innovative Sciences Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 6, 2013
    Initiation Date
    February 12, 2013
    Classification Date
    February 26, 2013
    Termination Date
    November 25, 2013
    Address
    1129 N Mcdowell Blvd, N/A, Petaluma, CA, 94954-1110, United States

    Description

    Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz.. RX only, Professional Sample, Not for Sale. Pre-printed tube: MS31071, Shelf carton: PL51091-08 Atrapro Antipruritic HydroGel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis and atopic dermatitis.

    Reason

    Out of specification result - stability test failure of free available chlorine (FAC) which functions as a preservative for the hydrogel. The 13 month test result obtained was 4 ppm FAC and the stability specification is >10 ppm FAC.

    Code Info

    Lot 12A0012, Exp 2/2013; Lot 12A0013, Exp 2/2013: Lot 12A1116, Exp 2.2013; Lot 12A1119, Exp 2/2013; Lot 12B1144, Exp 3/2013; Lot 12B1148, Exp 3/2013; Lot 12C1157, Exp 4/2013; Lot 12E190. Exp 6/2013; Lot 12E194, Exp 6/2013; Lot 12E198, Exp 6/2013; Lot 12E202. Exp 6/2013; Lot 12E208, Exp 6/2013; Lot 12E211, Exp 6/2013.

    Distribution

    Nationwide Distribution - One distributor in PA

    Quantity

    56,566 1.5 oz tubes