J&J chalks up ninth product recall in 2010
pharmafile | August 26, 2010 | News story | Manufacturing and Production |Â Â J&J, JJÂ
Johnson & Johnson has recalled around 100,000 boxes of its disposable contact lens because of a manufacturing defect, bringing the group’s product recall count this year to nine.
This time the recall is for the firm’s 1-Day Acuvue TrueEye daily disposable lenses in 30- or 90-count boxes manufactured at a facility in Ireland and distributed in Japan and various other countries in Europe, Australia and Asia.
The recall was initiated on 18 August after J&J’s Japanese subsidiary received complaints of pain stinging and eye irritation when the lenses were worn, according to a press release issued by J&J Japan, which stresses it does not anticipate any long-term health effects.
After internal investigations, the company believes the cause may lie in the lens cleaning process, and says it has implemented measures to correct the problem. Some of the affected lots had not been shipped by the time the adverse effects were discovered and have now been destroyed.
In the meantime, customers who have purchased the affected lots are being offered replacement product, said the firm.
The latest recall comes shortly after J&J announced a plan to beef up its quality control via the creation of a unified management team under the direction of Ajit Shetty, with quality managers assigned to each of its three operating divisions.
The restructuring plan for its manufacturing operations comes after eight prior recalls of non-prescription medicines, including millions of bottles of paediatric medicines, affecting some of its top brands including painkillers Tylenol (acetaminophen) and Motrin (ibuprofen) and the allergy treatment Benadryl (diphenhydramine).
The firm has also received letters from the FDA citing problems at a total of five separate manufacturing facilities.
The company is also being examined by a Congressional committee and the FDA’s Office of Criminal Investigations over its manufacturing problems.
Phil Taylor
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