Johnson & Johnson (JNJ.N), which has been beset by product recalls, on Wednesday confirmed that it recalled nearly five times as many contact lenses as the 100,000 boxes it announced in August due to eye stinging.
J&J said that in late October the recall of its 1 Day Acuvue TruEye lenses, which took place primarily in Japan, was expanded to a total of about 492,000 boxes. The New Jersey-based global healthcare conglomerate, which claims to be striving for greater transparency in the wake of a series of image-damaging recalls of over-the-counter medicines, said it announced the expanded recall by press release only in Japan, where some 75 percent of the affected product was sold, leaving J&J investors largely in the dark.
The company is already under criminal and congressional investigation in the United States over a series of massive recalls of such products as Children's Tylenol, Motrin and Benadryl due to quality control lapses and other problems.
The contact lens recall did not affect products sold in the U.S. market. The expanded recall came to light on Wednesday after details were posted on a UK healthcare regulatory agency website.
Regulatory authorities in all countries with affected lots were notified of the expanded recall in late October, said Gary Esterow, a spokesman for J&J's Vistakon vision care unit, leaving it up to the respective government agencies to notify consumers.
Some 25 nations in Europe were involved in the limited voluntary recall, including the UK, Sweden, Italy, Spain, Ireland, Switzerland and Germany. Acuvue lenses were also recalled in Canada, Australia, South Korea, Hong Kong, Malaysia, New Zealand and Singapore, the company said.
The nearly half a million recalled boxes represents less than 1 percent of all the contact lenses made by J&J worldwide, the company said.
The lens recalls were prompted by consumer complaints of stinging or pain upon inserting them in the eye. A J&J review identified higher-than-expected levels of a type of acid used in manufacturing the lenses that had not been fully removed during the lens rinsing process.
The review also turned up a small percentage of contact lenses that did not meet internal manufacturing requirements, Esterow said.
J&J shares were up 0.9 percent at $62.09 in afternoon trade on the New York Stock Exchange.