BEUDAMED
    FDA Recall 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 · Initiated February 12, 2013

    Recall

    Recall Number
    Z-0890-2013
    Event Number
    64316
    Firm
    Oculus Innovative Sciences Inc
    FEI Number
    3004554409
    Product Code
    FRO
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    February 12, 2013
    Posted
    February 26, 2013
    Terminated
    November 25, 2013
    Address
    1129 N Mcdowell Blvd, Petaluma, CA, 94954-1110

    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.

    Action

    Oculus sent an Urgent Medical Device Recall letter dated February 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue distribution and segregate the affected product. Immediately remove the affected lots of Recall product from the inventory of sales representative, sub contracted distribution and or fulfillment centers. Segregate the affected product in a secure location for return or destruction. If the product was further distributed customers were instructed to notify healthcare professionals of this recall. Customers were also instructed to completed and return the Business Reply Card and fax to 1-415-462-5163. Once the firm receives the affected product the customer would be contacted by an Oculus Representative and provided a Returns Goods Authorization (RGA) number. For questions customers were instructed to call 1-707-559-2445. For questions regarding this recall 707-559-7191, ext 14.

    Distribution

    Nationwide Distribution - One distributor in PA

    Quantity

    56,566 1.5 oz tubes