J&J Animas unit recalls leaky insulin cartridges
* 384,180 cartridges recalled in U.S., France
* 22 adverse events reported, no deaths
* Leak could result in underdelivery of insulin
* FDA also warns Cordis unit over stent manufacturing
* Shares close up 0.5 percent (Updates number of adverse events, closing share price)
By Bill Berkrot
NEW YORK, March 8 (Reuters) – Johnson & Johnson (JNJ.N), which has been beset by a seemingly endless stream of product recalls, has recalled hundreds of thousands of potentially leaky insulin pump cartridges that could lead to serious health problems and death.
It also has been warned by the U.S. Food and Drug Administration over manufacturing concerns for heart devices made at its Cordis unit’s San German, Puerto Rico, facility.
J&J’s Animas unit, the maker of the recalled 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 were blockage in the infusion set, Animas said.
There have been reports of 22 adverse events experienced by patients, but none involved hospitalization or death, Animas spokeswoman Caroline Pavis told Reuters.
A total of 384,180 2.0 milliliter insulin cartridges were recalled. They came from from five lots shipped in the United States and one in France between Nov. 30 and Jan. 4, according to Pavis and a letter posted on the Animas website that listed the specific U.S. recalled lot numbers.
Animas first learned of the problem through complaints from customers about insulin leaking from the plunger side of the cartridge, Pavis explained.
The total recall represents about 5 percent of yearly production, Pavis said.
In addition to sending letters about the potential problem to users of its pumps, Animas said it had informed physicians and the FDA about the recall.
Separately, the FDA warned J&J’s Cordis unit in a letter sent to the company on Feb. 16 about a failure to ensure that heart devices made at the Puerto Rico plant — such as stents used to prop open arteries — were manufactured with consistency.
Specifically, inspectors found that Cordis’ procedures did not prevent abnormal products or ensure that its devices met certain specifications, according the FDA’s letter, made public on Tuesday and posted on its website at 1.usa.gov/hqt0gW.
The FDA uncovered the problems when it inspected the plant in September and October. Although the company has since said it would take steps to address the issues, agency officials said in the letter that those steps either did not work or did not go far enough.
The FDA issues dozens of such warning letters a year, although most are resolved without further action. The agency, can, however, seek penalties such as injunctions or fines.
J&J’s once-golden reputation has been badly tarnished by manufacturing and quality control problems at its plants that have led to a series of recalls of widely used consumer healthcare medicines, such as Tylenol, Rolaids and Motrin, and of 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.
Shares of J&J closed up 31 cents, or 0.5 percent, at $60.71 on the New York Stock Exchange. (Reporting by Bill Berkrot; Additional reporting by Susan Heavey in Washington; Editing by Tim Dobbyn, Gerald E. McCormick and Matthew Lewis)