Problems with K-Y Liquibeads, O.B. Tampons Not Investigated: FDA Warns

Johnson & Johnson’s McNeil unit has received a warning letter from the FDA for failing to properly respond to consumer complaints about problems with K-Y Liquibeads vaginal moisturizer, O.B. Tampons and other products. 

The FDA warning letter arose from a December inspection of the company’s Skillman, New Jersey facility and comes only a year after Johnson & Johnson was forced to sign a consent decree where it promised that it would tackle quality control issues.

Most of the warning letter is focused on K-Y brand LiquiBeads Vaginal Moisturizer, indicating that McNeil failed to properly respond to nearly 70 complaints about the LiquiBeads, many of which mentioned problems getting the beads to dissolve or providing inconsistent lubrication. The company received 227 complaints involving problems with the vaginal moisturizer beads from June 25, 2010 through December 12, 2011.

Some cases where the beads reportedly did not dissolve properly or reportedly had uncharacteristic texture were closed by the manufacturer without any written justification, the FDA inspectors found. In some cases, the company reported that the lot numbers on the complaints were invalid and dismissed them, but FDA inspectors found that they were indeed valid numbers.

In addition to the complaints, the FDA says the company botched long-term stability studies for the LiquiBeads and did not properly test their compatibility with latex condoms.

The company also had problems responding to other complaints as well. Information about a patient diagnosed with toxic shock syndrome after using an O.B. tampon and another complaint involving a consumer who lost a tooth while using Reach dental floss were both submitted to the FDA later than regulations allow. The FDA says that since the inspection the company’s response to the delayed complaint submissions appears to be adequate.