The FDA has three classes of recalls it can request or order, with Class I recalls being the most serious. Those are for situations when there is a "reasonable probability" that use of what the agency refers to as a "violative product" will have serious consequences and could be fatal.
The FDA is now publishing press releases it sends out for Class I recalls going back to 2012. While the FDA says they may not be inclusive of all Class I recalls, they are one indication of a company's manufacturing standards. We decided to sort the data starting with 2012 and up through the first quarter of this year to see what might be learned.
There are 150 releases for recalls by 70 companies posted by the FDA over that period, 36 in 2012, 58 in 2013, 43 in 2014 and 13 in the first quarter of this year. One thing we quickly discerned was that 2013 was a bit of an aberration. That is because it came after the FDA crackdown on large compounding pharmacies, following the 2012 fungal meningitis outbreak that was tied to drugs manufactured by New England Compounding Center. We didn't include any of that data in our evaluation because, while the large compounders present some competition to drugmakers, they are in a category all of their own.
Another observation is that very few of the Class I recalls publicized were from Indian companies. That is mentioned because there has been so many FDA regulatory actions taken against Indian companies the last several years over data integrity questions and GMP issues. Ranbaxy Laboratories, which has been at the center of so much of that action, had only one Class I recall. Wockhardt is another Indian drugmaker whose failings have led to banned plants and recalls, but there were no Class I recalls from it in the data. Of course, there are two other levels of recalls and both companies have had recalls in those classes.
The company that tops the list will be no surprise to regular readers: It is sterile injectable maker Hospira ($HSP), which had more recalls listed in the data than all of the rest of those we included added together. Next comes Baxter International ($BAX), another sterile injectables company that is a regular in our coverage. Bedford Laboratories and Ben Venue, operations of Germany's Boehringer Ingelheim placed third with 5 recalls. The problems at the Bedford, OH, plant were notorious, and according to a consent decree, there were 40 recalls of all classes tied to it from 2002 to 2012. Since Boehringer temporarily closed the operation in 2011 for remediation and then shuttered it at the end of 2013, most of its recalls predate the posted data. The other two companies we included in the report each had four Class I recall releases in the data and those companies we have listed in alphabetical order.
Please read the following report and feel free to share any observations with Associate Editor Eric Sagonowsky or myself.