FDAnews
www.fdanews.com/articles/147093-j-amp-j-rsquo-s-mcneil-unit-warned-for-selling-unapproved-lubricant-mdr-lapses

J&J’s McNeil Unit Warned for Selling Unapproved Lubricant, MDR Lapses

June 8, 2012
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.
Devices & Diagnostics Letter