FDA Slaps J&J for Tampon, KY Trouble
(SKILLMAN, N.J.) -- The beleaguered consumer product giant Johnson & Johnson has had its hand slapped again by the FDA, this time for problems with tampons and other popular personal care products.
In a warning letter released Wednesday, the FDA admonished J&J’s McNeil unit for failing to adequately follow up on a range of consumer complaints. The most serious of the complaints includes a report of a woman who suffered from toxic shock syndrome after using an O.B. tampon.
McNeil’s plant in Skillman, N.J., manufactures a variety of personal care products, including O.B. tampons, Carefree and Stayfree menstrual napkins, KY brand lubricant and moisturizing products, as well as Reach dental floss.
In the reported case of toxic shock syndrome, J&J waited more than a month before alerting the FDA. And in a separate incident, J&J failed to tell the FDA that a consumer had lost a tooth while using Reach floss.
But the latest and most extensive list of offenses involved KY Liquibeads Vaginal Moisturizer. J&J markets Liquibeads as an “ovule insert” that contains a “premium quality silicone formula” that “dissolves within minutes, locking in your body’s natural moisture and keeping intimate skin hydrated while enhancing comfort.”
For 227 consumers, who complained to J&J between June 2010 and December 2011, the Liquibeads did not live up to those promises of “enhanced comfort” or “more enjoyable” intimacy. Yet the company filed away such complaints -- under headings like “does not dissolve,” “uncharacteristic consistency/texture and “does not perform as expected.” The complaints were not, the FDA said, “adequately evaluated or investigated.”
The agency’s warning letter also raised questions about whether Liquibeads should be on the market at all, given the manufacturer’s failure to prove that the moisturizer is compatible for use with latex condoms.
J&J has until early June to outline a plan to correct the problems.
“We take the issues raised by the FDA seriously,” McNeill PPC, Inc. said in a statement to ABC News. “We will respond fully to their concerns and take whatever steps are needed to resolve these issues.”
This chiding from the FDA is only the latest in a string of problems that has plagued J&J in recent years. In 2010, metal and wood particles were found in 13 million packages of Rolaids. In 2011, J&J’s Ethicon was sued by more than 100 women citing negligence and defective product design of the vaginal mesh, Gynecare Prolift. And in March, J&J recalled, yet again, thousands of bottles of Tylenol 8 Hour Extended Release Caplets.
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