The FDA cast a wider net this year as it sent inspectors into what it called 30 "high risk" compounding pharmacies, those that made sterile drugs that can easily be contaminated. The scrutiny has had a pronounced effect on the number of recalls the agency has ordered.
The FDA has ordered many of the compounders it looked at to recall all of their sterile products after finding less-than-impressive sterility procedures and conditions at the operations. That contributed to a 32% jump in recalls in the first quarter of 2013, according to the ExpertRECALL Index from Stericycle. There were 107 recalls in the first three months of the year, the recall assistance company reported. That number is higher than the average for all of last year.
The index found that unit recalls were also up, with more than 13.1 million units being retrieved, compared to about 11.7 million in the fourth quarter of 2012. Three recalls involved more than 1 million units and 5 involved between 500,000 and 1 million, the company said. Of those, 14 were Class I recalls, 62 were Class II and 31 were Class III. Class I recalls were up more than 100%. There were 101 recalls of prescription drugs and 6 recalls of over-the-counter products.
There has been a steady drumbeat of action since the FDA took on inspections of the largest compounders. The ExpertRECALL report says one compounder had 13 recalls in the quarter. The scrutiny followed last year's outbreak of meningitis tied to a steroid made by the now-defunct New England Compounding Center that sickened more than 700 patients and led to more than 50 deaths.
The report does not identify which companies were targeted for recalls, but not all of the manufacturing problems were at compounders. There have been significant numbers of recalls by some of the best-known drugmakers, including Hospira ($HSP), the largest maker of generic sterile injectable drugs in the U.S. There were also a couple of high-profile recalls of OTC products. Novartis ($NVS) had to recall 183 lots of cough and cold products made at its troubled Lincoln, NE, plant, after parents reported that some children had managed to pop their "child proof" lids. One child had to be hospitalized after getting into one of the bottles and taking a drink.
- read the Stericycle report
- here's the release