Why Are American Product Recalls Occurring? Part 4

Taking medication has become a routine procedure. Whether medication is prescribed by a doctor or is purchased over-the counter (OTC), consumers oftentimes place complete trust in the fact that what they are taking will cure them of their maladies. 

And, rightfully so; medication is something that should not have to be questioned.

But some drugs that appear to be consumer friendly are turning out to be deadly, in large part due to a lack manufacturing quality control. When enough of these problems are discovered, usually by consumer injury or death, a product recall is the only way to get them back. And, sadly, drugs are often quickly taken, abused and distributed illegally—making recalls very difficult.

Until manufacturing quality control becomes a standard industry practice, we are going to have to keep looking at alarming statistics related to product recalls. Consider the following statistics collected by the FDA Enforcement Reports during the fourth quarter of 2012:

  • Three product recalls affected between one and five million units.
  • 42 companies were affected by pharmaceutical recalls with 19 facing more than one recall; this is the highest number reported in 10 quarters.

According to the FDA, in the fourth quarter of 2012 there were 81 documented drug and pharmaceutical recalls, meaning 11.1 million units were affected. While the number of recalled units was lower than the third quarter, it was still a gain of 50,000 units when compared to the second quarter of 2012. Of those 81 recalls, 10 were considered Class I, which is the deadliest level. Fifty-one recalls were considered Class II, and 20 were designated as Class III.

Of the 81 documented recalls, only four were found in OTC products—meaning that what should be the most regulated drugs are posing the greatest risk to consumers. Further, one OTC Class III recall affected at least 1.5 million units. The remaining three products from the four OTC drugs that were recalled were Class I. Further, seventy-seven recalls pertained to prescription medications.

It should be noted that product recalls during the fourth quarter of 2012 did not just affect U.S. consumers. There were 42 product recalls relating to customers in the U.S. and 28 in the U.S. and one other nation or territory.

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