The Most Serious Kind Of Drug Recall Is Increasing

http://www.pharmalive.com/the-most-serious-kind-of-drug-recall-is-increasing/

A reminder that a class I designation means there's a reasonable probability of causing serious adverse health consequences or death.

Posted Thu, 05/16/2013 - 11:27am by Ed Silverman 1

Amid an FDA crackdown on manufacturing violations and a rising shortage of many prescription drugs, it may not be surprising to learn that there were also more recalls during the first quarter of this year.

Specifically, there were 107 recalls, which amounted to a 32 percent increase from the previous quarter and a higher number, on average, according to a report from Expert Recall, a consulting firm.

And given the increased scrutiny placed on compounding pharmacies by the FDA in the wake of the nationwide outbreak of fungal meningitis last fall, a compounder set the record for most recalls in this year’s first quarter with a total of 13.

Overall, there more than 13.1 million unit recalls, up from 11.7 million in the fourth quarter of 2012. The bulk were due to several large recalls, including that involved more than 1 million units each.

Interestingly, there were 14 Class I recalls this past quarter, which was more was document in each quarter of 2012. This is the most serious because these suggest what the FDA calls a reasonable probability that use or exposure will cause serious adverse consequences or death.

Similarly, there were more Class II and Class III recalls in the recently ended quarter than in each quarter during 2012. The number of Class II recalls amounted to 62 and the number of Class III recalls totaled 31.

In a further breakdown, six recalls involved over-the-counter medicines and three “high volume” products accounted for 85 percent of the total. The drugs, however, were not named.

The remainder of the 107 recalls involved prescription drugs, including 14 that were documented as Class I, 61 were Class II and 26 were Class III. And 67 recalls affected US customers nationwide. Only one recall affected customers outside the US.

Here is the report link:
http://www.expertrecall.com/wp-content/uploads/Q1-2013_Pharmaceutical-Recalls.pdf