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

June 7, 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.

Among other allegations, the letter states that McNeil marketed K-Y Liquibeads vaginal moisturizer without premarket approval. A PMA was required because McNeil had made significant changes made from the predicate device, “such as the implementation of a gel capsule delivery system, the use of an applicator, and significant labeling changes,” the letter explains.

McNeil also failed to investigate customer complaints on K-Y Liquibeads, including 68 medical complaints, the letter states. At least 28 complaints categorized as “does not perform as expected” were closed without further investigation.

Complaints requiring the filing of a medical device report (MDR) also were not addressed correctly, inspectors said. Nine of 19 MDR-reportable complaints were missing information, inspectors found. This was a repeat of conditions found during a 2009 Skillman inspection. In the most recent cases, one customer reported losing a tooth while using Reach floss and another reported toxic shock syndrome after using an O.B. tampon. The FDA concluded McNeil’s response to those issues was adequate.

“We take the issues raised by the FDA seriously,” said J&J spokeswoman Jodie Wertheim. “We will respond fully to their concerns and take whatever steps are needed to resolve these issues.”

McNeil has been plagued by recent recalls on OTC drug products, such as infant Tylenol, Benadryl and Motrin, and it had been hoped new J&J CEO Alex Gorsky would be able to get the business
unit back on track (GMP, March). — Elizabeth Orr