A report published this week by the recall consulting group ExpertRecall analyzing the number of recalls in the regulated healthcare product sector shows that both pharmaceutical and medical device recalls continued to fall within historical norms, even as both fluctuated-for better and for worse-from previous quarters.
Background
In the US, the recall of pharmaceutical and medical device products is largely conducted on a voluntary basis by companies, who often wish to avoid the bad publicity and legal expenses that result when FDA seeks a legal order compelling it to do so.
Those recalls fall into three general categories: Class III, II and I recalls. Class I represent the most serious potential for immediate and lasting harms, including the potential for death. Class II recalls are less serious than Class I, and represent reversible harms. Class III recalls are for the least serious problems.
It can be useful, then, to keep track of the number of recalls affecting a given industry. A large number of Class I recalls would seem to indicate endemic quality problems throughout the industry, while a small number would indicate better attention to quality manufacturing.
Pharmaceutical Recalls: Mixed News
ExpertRecall's newest quarterly installment of its recall reporting series is now out, and with it new insights into the state of the medical device and pharmaceutical industries.
On the pharmaceutical side, recalls were down sharply from Q2 2013 through Q3 2013, though well within historical norms. The third quarter saw 171 pharmaceutical recalls affecting 27,495,000 units-a 27% decrease in the number of recalls from the previous quarter, but a 58.4% increase in the number of recalled units. However, the report said this was mostly the result of a single manufacturer recalling more than 8 million units.
In addition, a surge in pharmaceutical compounding problems resulted in 20 total recalls, many of which were Class I. This was more than double the previous quarter's compounding-related recalls (9).
The increase in affected units aside, nearly all recall areas saw a decrease in the pharmaceutical sector during the third quarter. Just 16 recalls were Class I, 124 Class II and 31 Class III. The second quarter, meanwhile, saw 22 Class I, 175 Class II and 44 Class III.
Device Recalls See Surge
Medical devices, meanwhile, saw an increase in both the number of recalls and the number of device units affected, though like the pharmaceutical sector, both trends were close to-though above-historical norms.
The third quarter saw 415 device recalls, a 1% increase above the previous quarter and the highest number in the last year. The number of recalled devices, however, shot up 215% to 29 million units in Q3, again the highest amount in five quarters.
The recalls affected 171 companies, of which 36% conducted more than one recall, including one with 23 recalls and nine with more than 10 recalls each.
As with pharmaceutical recall, the majority (90%) of products affected were recalled under a Class II recall classification, while the remainder were split about 2:1 between Class III and Class I.
Stericycle - Q3 2013 Recall Report
Stericycle - Q2 2013 Recall Report
Stericycle - Q1 2013 Recall Report