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Suprep unsafe, 483's, infestations

Discussion in 'Pharma Contract Manufacturing - General Discussion' started by Anonymous, Jan 14, 2012 at 2:13 PM.

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  1. #1 Anonymous, Jan 14, 2012 at 2:13 PM
    Anonymous

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    Suprep Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution, 17.5g/3.13g/1.6g per 6 ounces, Kit contains: 2 6-ounce bottles of liquid bowel prep, 1 16-ounce mixing container, 1 patient booklet, Rx Only, NDC: 52268-012-01. Recall # D-837-2012
    CODE
    Lot #: 2811015, Exp. 07/13
    RECALLING FIRM/MANUFACTURER
    Braintree Laboratories, Inc., Braintree, MA, by letter on October 19, 2011. Firm initiated recall is ongoing.
    REASON
    Labeling: Correct Labeled Product Miscart/Mispack; Missing product labeling on white carton containing the kit contents. However, each kit carton is loaded with properly labeled Suprep oral solution bottles, patient instructions for use, package insert/medication guide and mixing container.
    VOLUME OF PRODUCT IN COMMERCE
    25,134 kit cartons
    DISTRIBUTION
    Nationwide
     
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