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FDA: J&J unit McNeill hid complaints on OB Tampons, KY Liquibeads

Filed May 31st, 2012 Laurie

Medical products giant Johnson & Johnson is facing criticism from the Food and Drug Administration because it failed to communicate customer complaints about a line of its tampons and because it never received approval to sell its KY Liquibeads.

According to a Reuters report, the FDA has sent a warning letter to J&J’s McNeill PPC Inc. unit over complaints the company received about its O.B. tampons. Numerous complaints had been filed by women who suffered toxic shock syndrome while using the products in question. When a company making medical products that require FDA approval, any complaints received about those products must be relayed to the agency in two weeks’ time.

The company held to a similar practice on complaints it received about its KY Liquibeads product, similar to its KY lubricating jelly. The reasons for not reporting those complaints is understandable but certainly not justified. According to the report, McNeill or J&J never received approval to sell this product. The FDA, in its letter, states that the composition of Liquibeads is considerably different than its top-selling KY products currently on the market, including the use of an unknown lubricant.

McNeill received 227 complaints about Liquibeads from consumers who purchased them. Most complaints involved the beads not dissolving or for the lubricant having an “uncharacteristic consistency.”

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