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  • za84 replied to the topic Safety Recalls in the forum Introduction to Project Management 6 years, 11 months ago

    I would agree with the reviews above which thinks that a product with a peeled off label or similar defects should still be recalled as they may lead to a severe dangerous consequence in some cases. For example, a pain relief medicine that is unsafe to be used by a pregnant woman (such as Aspirin, Ibuprofen, Herbs, minerals, etc.) and the content label or ingredient label was not clear enough to show that important information to the patient. In this case, the label could have prevented a risk for the mother and the baby and I think a safety recall should be required.

    This can be applied to any medical device or anything related to human health as any information is essential and needed by the user and the market and labeling approval by the FDA should be reviewed.

    I found an interesting link related which is an example of this topic regarding “Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up”
    https://www.fda.gov/Safety/Recalls/ucm618583.htm