Johnson & Johnson Take Heat From FDA
Monday, January 18th, 2010Johnson & Johnson became the target of the FDA’s wrath on Friday due to a delayed recall of approximately 500 lots of drugs like Tylenol, Motrin, and Benadryl.
Apparently J&J had received many complaints from consumers early in 2008 stating that some of there medications had a moldy, mildew-like odor. J&J chose to overlook these complaints, until late in 2008 when the FDA issued a warning letter to J&J stating that failure to rectify the problem could result in legal action and seizure.
Despite knowing that they were selling sub par products, a recall was not initiated until last month, drawing public criticism from the FDA on Friday.
McNeil (sub company of J&J) should have acted faster,” said Deborah Autor, director of the FDA’s Office of Compliance, of the arm of Johnson & Johnson that manufactures Tylenol products, adding “When something smells bad, literally or figuratively, they must aggressively investigate and solve the problem.”
The FDA further criticized J&J for not adequately responding to complaints, noting the extremely long length of time from when they had first received complaints of the odor, to when action was taken to remedy the problem.
The recall has been made on the Tylenol Arthritis medication that was the original source of the problem, as well as Tylenol Extra Strength, Rolaids, and a number of children’s medicines that appear to have the same problem.
If the tainted medicine is taken, individuals may experience a number of side affects including nausea and vomiting.
If you have purchased any of these tainted J&J medications, the company advises consumers to stop using them and contact McNeil for information about how to get a refund or a replacement. The company provided the address for its Web site, www.mcneilproductrecall.com, as well as a toll-free number: (888) 222-6036.
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