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Synthroid 150 mcg

Discussion in 'Product Recalls' started by Ellen, Jan 15, 2013.

  1. Ellen

    Ellen Senior Member

    Joined:
    Oct 22, 2005
    Messages:
    8,240
    Enforcement Report - Week of January 9, 2013

    FDA Home Enforcement Reports

    Product Detail
    Product Description Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC 0074-7069-90; ABBOTT LABORATORIES NORTH CHICAGO, IL 60064 U.S.A.
    Recall Number D-107-2013
    Classification Class II
    Code Info LOT # 18262A8 Exp. 09/13
    Product Distributed Qty 28, 524 bottles
    Reason For Recall Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
    Event Detail
    Event Id 63791
    Product Type Drugs
    Status Ongoing
    Recalling Firm Abbott Laboratories
    City Abbott Park
    State IL
    Country US
    Voluntary / Mandated Voluntary: Firm Initiated
    Recall Initiation Date 2012-12-04
    Initial Firm Notification of Consignee or Public Letter
    Distribution Pattern US Nationwide and Puerto Rico
     

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