1. GSK takes RSV maternal vaccine candidate into phase 3 testing — FDA approves Alnylam's first-ever drug for rare kidney disease — FDA approves Roche's Xofluza to prevent flu spreading within families — See more on our front page news Stay updated with the latest pharma-related coronavirus news on our new page
    Dismiss Notice
  2. Please take our quick survey on how COVID-19 is impacting your job It will only take a minute or two to respond. The survey is confidential, and does not require registration. Thank you in advance for your participation. We will provide regular updates on results as responses accumulate.
    Dismiss Notice
Latest trending news COVID-19 and your job

Suprep unsafe, 483's, infestations

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

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

    Anonymous Guest

    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
     
    Quote

Reply to Thread