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.
Read more: Recalls jump 32% in first quarter - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/recalls-jump-32-first-quarter/2013-05-16#ixzz2TV0MM8pg
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