Latest J&J Recall Involves Sterility-Risk Sutures

Johnson & Johnson, which has been plagued by repeated recalls of its consumer medicines and medical devices over the past year, on Wednesday said it recalled 107 batches of surgical sutures in December due to potential sterility problems.

The recall came to light on Wednesday after the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) described the action on the agency's website.

The diversified healthcare company said the voluntary recall took place mostly in Europe and involved a total of 585,000 individual strands of sutures. The action stemmed from potentially faulty packaging seals on the individually wrapped sutures that raised a contamination risk, J&J said.

The potential problem was caused by modifications of manufacturing equipment and has been corrected, said Barbara Montresor, a spokeswoman for J&J's Ethicon surgical products division.
"The company has not received any reports of adverse events related to these occurrences," she said, noting that none of the sutures were distributed in the United States.

The sutures were sold under the brand names Ethilon, Ethibond, Mersilene and Mersilk.

Montresor said J&J immediately notified regulators of the December 29 recall. Asked why the public was not notified, she said largely because the affected sutures were quickly isolated and withdrawn from the market.

The recall came to light on Wednesday after the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) described the action on the agency's website.

The Ethicon unit last month disclosed it had recalled a hernia repair product whose packaging was also deemed prone to contamination, as well as 700,000 vials of a liquid wound sealant due to reports some were discolored.

Only days earlier, J&J said it was recalling 70,000 syringes of its Invega Sustenna anti-psychotic medicine because of cracks found in the syringes.

Those actions followed repeated recalls of Tylenol, Motrin, Rolaids and other widely used J&J consumer medicines due to quality control lapses. The recalls, involving hundreds of millions of packages, badly tarnished the company's reputation and cost J&J almost $1 billion in lost sales in 2010.

Continuing shortages of the products will also crimp J&J's revenue and earnings in 2011, as the company continues to upgrade deficient factories.

Company Chief Executive Officer William Weldon has said he expects all the consumer products to return to store shelves this year.