Animas, which claims its goal is to find "ways to make diabetes exceedingly manageable in every way," notified diabetic patients of the problem in a Feb. 24 letter after learning of several cases of leaking cartridges. The recall, Animas said, affects 2-milliliter cartridges shipped between Nov. 30 and Jan. 4.
The cartridges "can leak insulin, resulting in the delivery of less insulin than intended." The leaking cartridges may also prevent the insulin pump from sounding an alarm if there is a blockage in the infusion system, the letter said, and then emphasized:
Animas said it would replace the cartridges for free, and added it had also notified the Food and Drug Administration about the recall and informed physicians. According to Pharmalot, the recalled batch includes 45,000 faulty insulin cartridges.Please note that under-delivery of insulin can cause high blood sugar and/or diabetic ketoacidosis. These are serious conditions that can cause severe health impact, including death.
FDA Also Warns About Stent Manufacturing Issues
In a separate matter, the New Brunswick, N.J., company also has received a warning letter from the FDA over manufacturing violations involving cardiovascular devices such as stents made at its Cordis unit's facility in San German, Puerto Rico.
This is a recurring issue at the plant: The FDA uncovered similar problems when it inspected it previously. The FDA letter notes that the responses so far from the company have been insufficient. "You should take prompt action to correct the violations addressed in this letter," the FDA wrote.
The small recall and the warning letter -- a form issued by the FDA to dozens of manufacturers -- would have likely been largely ignored if it weren't for the fact that J&J, the world's largest consumer health care company, has been plagued by massive recalls since 2009 that cost it $900 million in sales last year. The recalls of widely used products ranging from over-the-counter children's cold medicines to contact lenses have varied in severity, too -- from typos to leaky insulin cartridges to faulty hip implants.
As for the latter, J&J also took a product-liability charge related to the recall of certain DePuy hip implants of $922 million. On Monday, the president of DePuy Orthopaedics apparently "resigned his position to pursue outside interests," according to Dow Jones Newswires.
J&J's head honcho, however, Bill Weldon is not only staying for now, he even received a pay raise, despite overseeing a year of stunning recalls.