Johnson & Johnson, which has been beset by a seemingly endless stream of product recalls, has recalled five lots of potentially leaky insulin pump cartridges that could lead to serious health problems and death.
J&J's Animas unit, the maker of the cartridges and insulin pumps in which they are used by diabetics, said in a letter to patients last month that it found some of the cartridges can leak, resulting in delivery of less insulin than intended.
Insufficient insulin can cause high blood sugar and a serious condition known as diabetic ketoacidosis, which can be fatal. A leaking cartridge could also cause the pump to fail to sound an alarm if there is blockage in the infusion set, Animas said.
The company did not immediately return calls seeking information about the specific number of recalled cartridges or if there have been reports of harm to any patients.
The affected 2.0 mL insulin cartridges were shipped in the United States between Nov 30 and Jan 4, according to the letter posted on the Animas website that listed the specific recalled lot numbers.
In addition to sending letters about the potential problem to users of its pumps, Animas said it had informed physicians and the U.S. Food and Drug Administration about the recall.
J&J's once golden reputation has been badly tarnished by manufacturing and quality control problems at its plants that has led to a series of recalls of widely used consumer healthcare medicines, such as Tylenol, Rolaids and Motrin, medical devices and other products, including syringes and sutures.
The recalls, especially those of more than 250 million bottles and packages of its consumer healthcare products, cost J&J nearly $1 billion in lost sales in 2010 and are likely to hit revenue and earnings again this year as the company works to return affected products to pharmacy and supermarket shelves.