Regulatory Focus™ > News Articles > Pharmaceutical, Device Recalls Spike in Second Quarter, Led by Compounding and Global Trends

Pharmaceutical, Device Recalls Spike in Second Quarter, Led by Compounding and Global Trends

Posted 20 August 2013 | By Alexander Gaffney, RAC

Pharmaceutical recalls, and especially serious Class I pharmaceutical recalls, are up substantially from previous quarters, according to a new report from the recall consulting firm Stericycle.

The reports, which Stericycle publishes on a quarterly basis, serve as a snapshot of several industries, including the pharmaceutical and medical device industries, breaking down recalls by time, product type and recall severity.

Pharmaceutical Trends

Pharmaceutical recalls saw a massive spike in the second quarter of 2013, led primarily by a surge in Class II recalls, which are FDA's second most serious classification and reflect the potential for serious but non-life-threatening harm.

Just how large was this surge? To place it into perspective: The fourth quarter of 2012 saw approximately 75 recalls; the first quarter of 2013, a little more than 100. The second quarter of 2013, however, has seen 241 recalls, an increase of 127% over the previous quarter.

More than 17.3 million pharmaceutical units were affected as well, the report noted, with 12 recalls affecting more than 500,000 units.

Though Class I recalls increased slightly over the prior quarter from 14 to 22, the real increase was in Class II recalls, which surged from 62 to 175 from the previous quarter. And, as noted by the report, just five companies accounted for 65% of all recalled units in the second quarter.

In addition, recalls related to compounding practices were largely to blame for the rise in recalls, with just two pharmacies accounting for 104 recalls between them-more than 43% of all recalls for the second quarter.

Medical Device Trends

But while pharmaceutical products continued to receive the majority of attention, medical device products also saw a sizeable spike in recalls relative to the previous quarter, though well within historical trends.

While both Class I and II recalls increased relative to the previous quarter, the biggest trends of all had to do with the size and scope of the recalls, the report says. There was a 50% decrease in the number of units affected by recalls in Q2 2013-"the lowest level of units affected in six quarters." But even as the number of products decreased, the global scope of the recalls did.

"Nearly one out of every two medical device recalls this quarter occurred on a global scale," Stericycle wrote. "Additionally, recall activity reached a five-quarter high. With the significant number of recalls combined with the global nature of the recall environment, medical device manufacturers must be well-versed in the regulatory environments within countries they operate in as well as capable of managing the logistical complexities of a global recall."

Stericycle - Q2 2013 Recall Report

Stericycle - Q1 2013 Recall Report

Regulatory Focus newsletters

All the biggest regulatory news and happenings.