Adding to its lengthy list of recent recalls, Johnson & Johnson has called back hundreds of thousands of cartridges for insulin pumps because of possible leaks that could threaten the health of diabetes patients.
If a pump fails to deliver sufficient insulin, a patient could suffer high blood sugar and a potentially fatal condition known as diabetic ketoacidosis. Leaking also could prevent the pump from sounding an alarm if there is a blockage in the infusion mechanism.
J&J’s Animas unit said in a letter to patients that it “learned of several cases where a leak has occurred at the plunger side of the cartridge resulting in under-delivery of insulin.” A company spokeswoman told Reuters that there have been reports of two adverse events experienced by patients, but neither involved hospitalization or death.
The recall includes 384,180 of the company’s 2.0 milliliter cartridges shipped in five lots between Nov. 30 and Jan. 4. It amounts to about 5 percent of yearly production. “Once the cartridges are replaced, the pump will function as intended,” Animas said. “There is not a problem with the pump.”
Separately, the Food and Drug Administration has warned J&J’s Cordis unit about problems with the manufacturing of heart devices — such as stents used to prop open arteries — at a plant in Puerto Rico. According to the warning letter, inspectors who visited the plant last fall found that Cordis’ quality-control procedures did not prevent “nonconforming” products or ensure that its devices met certain specifications.
J&J’s recall-related problems, according to Reuters, cost the company nearly $1 billion in lost sales in 2010 and are likely to hurt it financially this year, too. Top-selling consumer health care products subject to recent recalls have included Rolaids and Mylanta antacids and Tylenol and Motrin painkillers.
The Indianapolis Star reported earlier this month that antacid recalls, including those of Rolaids and Mylanta, “have left store shelves empty, [with] retailers scrambling to increase production of store-brand knockoffs and consumers wondering what’s going on.”
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