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  • Scott replied to the topic FDA on Recalled Items in the forum Regulatory Basics for Medical Devices 8 years, 3 months ago

    The Tylenol Recall in 1982 was what started the idea of recalling products off shelves. Johnson and Johnson had to deal with this issue and James Burke, the CEO at the time, was commended for the way he handled the entire issue. The issue arose when several people died due to cyanide-laced Tylenol capsules. As a result, he recalled all the products on the shelves and they re-configured the packaging of the Tylenol. It ended up being a really quick turnaround and Johnson and Johnson was able to recover the market share that they had lost due to the incident.

    Was the FDA responsible for this? No. However, this did contribute to more stringent rules an regulations toward packaging of products and product labeling.