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FDAnews Device Daily Bulletin
June 8, 2012 | Vol. 9 No. 113
J&J’s McNeil Unit Warned for Selling Unapproved Lubricant, MDR Lapses
Johnson & Johnson (J&J) subsidiary McNeil received an FDA warning letter on a variety of violations related to personal lubricants, feminine hygiene products and other consumer goods. Several varieties of K-Y Jelly were named in the letter, as were Visine contact lens solution, O.B. tampons, Reach dental floss, and Stayfree and Carefree menstrual napkins. The May 22 letter followed a Dec. 12, 2011, to Jan. 19, 2012, inspection of McNeil’s Skillman, N.J., plant.
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