Fraught with product recalls and investigations, pharmaceutical giant Johnson & Johnson continues to make headlines. This time, because the drug maker is expanding a prior recall—it’s ninth recall in 2010 alone—of its 1 Day Acuvue TruEye Contact Lenses, said Reuters. Johnson & Johnson said it has recalled almost five times as many lenses as originally […]
Fraught with product recalls and investigations, pharmaceutical giant Johnson & Johnson continues to make headlines. This time, because the drug maker is expanding a prior recall—it’s ninth recall in 2010 alone—of its <"https://www.yourlawyer.com/practice_areas/defective_medical_devices">1 Day Acuvue TruEye Contact Lenses, said Reuters.
Johnson & Johnson said it has recalled almost five times as many lenses as originally recalled—100,000 boxes in August—over issues that prompted complaints of stinging eyes, according to Reuters. Johnson & Johnson expanded its recall, which took place in Japan, to 492,000 boxes, added Reuters.
The drug maker said it announced the expansion by press release and only in Japan, said Reuters, which pointed out that Johnson & Johnson has said it’s working toward increased transparency. Despite its claims of working to be more open, the announcement was not released to investors and was only released in Japan, where about 75 percent of the defective product was recalled, noted Reuters.
We recently wrote that Johnson & Johnson is expecting more legal fallout from its recalls of children’s Tylenol and other over-the-counter medicines. According to a prior Wall Street Journal report, Johnson & Johnson said in its most recent regulatory filing that it received “civil investigative demands†from various state authorities in connection with the recalls. In its Securities and Exchange Commission (SEC) filing, Johnson & Johnson disclosed it received multiple subpoenas from federal prosecutors requesting documents “broadly relating to†both the recent recalls and inspections of two factories and said it received demands from multiple State Attorneys General Offices relating to the same issues.
The New Jersey-based company has been hit with a federal subpoena from the U.S. Attorney’s Office for the Eastern District of Pennsylvania. The Journal also wrote that Congress is investigating the recalls, which have spawned numerous lawsuits.
Johnson & Johnson has been under scrutiny since April 30, when its McNeil Consumer Healthcare unit recalled more than 40 varieties of children’s Tylenol and other medicines. That recall was just one of six McNeil issued for its cold and pain relief products over the past year.
News of the recall was made yesterday after information was posted on a United Kingdom healthcare regulatory agency website, said Reuters, which said that none of the defective lenses were sold in the U.S. market. According to Gary Esterow, a spokesman for J&J’s Vistakon vision care unit, notification was made to regulatory authorities in all impacted countries and that it was up to each government’s agencies to notify consumers, reported Reuters. Twenty-five European nations were involved, including the UK, Sweden, Italy, Spain, Ireland, Switzerland, and Germany; lenses were also recalled in Canada, Australia, South Korea, Hong Kong, Malaysia, New Zealand, and Singapore, said Johnson and Johnson, according to Reuters.
The issue related to equipment failure that occurred when lenses are rinsed during production. It seems a substance used during manufacturing was not removed during the rinse process. At the time, Johnson & Johnson described the incident as “an isolated issue in one portion of the lens rinsing process on a particular manufacturing line affecting a limited number of lots,†quoted Medical News Today previously.
