Drug Recalls on the Rise Dramatically by 444 Percent

Drug Recalls on the Rise Dramatically by 444 Percent

The last quarter saw more drug recalls than at any time in the past three years. The number of recalls increased by 6 percent over the prior quarter to 86, and the volume of drug units in homes and on store shelves increased by 444 percent. The source of that information is Recall Index released today by Stericycle ExpertSOLUTIONS (NASDAQ: SRCL).

What is of greatest concern about the news is the number of Class I situations. The FDA (Food and Drug Administration) those as as carrying the highest risk of serious adverse consequences or death. There were 11.6 million Class I pharmaceutical units recalled in Q2, making it the highest since at least 2004. The greatest number of drug units recalls was was due to “superpotency.” Superpotency is the presence of too much of a drug’s active ingredient. The greatest number of drug recalls (as opposed to the greatest number of drug units recalled) was due to the presence of foreign substances like hair.

Drug Recalls Up in a Variety of Verticals

According to Stericycle:

The trend in Class I recall activity affects several other vertical markets as well, including medical devices and food & beverage:

  • Class I recalls in medical devices were up 88 percent largely caused by a quality issue, such as a part or section of the device that may detach or malfunction in a particularly dangerous way.
  • FDA Class I food recalled units were up 340 percent with the top cause being bacterial contamination from salmonella.
  • USDA Class I food recalls were up 86 percent, while USDA Class I food recalled units were up 561 percent. The top cause for both recalls and recalled units was undeclared allergen, mostly milk.

“The number of Class I units recalled in Q2 increased nearly 45 thousand times over the previous quarter. That is a tough pill to swallow,” said Michael Good, Vice President of Marketing & Sales Operations, Stericycle ExpertSOLUTIONS. “The top cause of these recalls was, of all things, a foreign material like hair. This spike in both high-risk and overall recall activity should be a red flag for the industry.”

For more information about drug recalls, click here.


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