Another drug recall occurred this week as the FDA has told providers to stop using contaminated IV medications made by Claris Lifesciences in a factory in India. Providers have been warned not to use the company’s intravenous metronidazole, ondansetron, and ciprofloxacin.
Following on the heels of the much-publicized McNeil recalls last month, this latest FDA advisory hit the same week as a Gold Sheet report that the number of US drug recalls rose sharply in 2009. The record 1,742 drug recalls the FDA listed last year is due mainly to a spike in good manufacturing practice (GMP) violations, which may signal a breakdown of quality control but also increased regulatory vigilance on the part of the FDA.
At least one of the Claris IV bags analyzed by FDA contained Cladosporium mold that can cause human infection, especially in immuno-compromised individuals.
Thought the recent McNeil recalls of pediatric meds has received the most headlines, the biggest recall last year was by a Shreveport-based repackager called Advantage Dosing, which issued 1016 recalls at the end of 2008. Drug companies Apotex, Caraco and Teva were also among the top recallers.
The report indicates that recalls of drugs made overseas more than doubled from 2008. Though still up a small proportion of total recalls – 10 percent this year – the Gold Sheet says that number is likely to grow further as FDA increases its foreign inspection capacity.
As Congress contemplates giving FDA mandatory recall authority (an authority the deputy commissioner asked for at a hearing this spring), the agency has recently taken steps to shore up its enforcement. Even quicker reporting—it takes the agency one-third the time to post recalls in its weekly enforcement bulletin that it did before the Obama Administration took office—suggests a stepped-up vigilance, the Gold Sheet says.
To learn more about steps toward securing a safe drug supply, visit the Pew Prescription Project.
–Kate Petersen, PostScript blogger