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  • hc255 replied to the topic FDA on Recalled Items in the forum Regulatory Basics for Medical Devices 8 years, 2 months ago

    In 2015, Medline Industries, Inc. had a voluntary recall of one lot of acetaminophen tablets. The issue here was that the bottles were incorrectly labeled as showing 325mg instead of 500mg. The risk of this issue comes from possible maximum dosage intake that may lead to liver toxicity/failure. As a means to prevent and correct this error, a CAPA was issued. I believe since this is a voluntary recall by the company, FDA is not responsible for this recall. However, FDA would be if they found this issue.

    https://www.fda.gov/Safety/Recalls/ArchiveRecalls/2015/ucm467049.htm