According to a warning letter posted on the FDA’s website, the Food and Drug Administration (FDA) said that a Johnson & Johnson (J&J) unit did not properly follow up on complaints about O.B. Tampons and about a personal lubricant similar to K-Y Jelly, reports Reuters.
Some of the complaints included toxic shock syndrome from using the tampons and the K-Y Liquibeads’ not dissolving or having an “uncharacteristic” consistency.
The FDA said that J&J never got permission to sell the K-Y Liquibeads. The FDA said that the company never told regulators that it planned to sell the K-Y lubricant and made substantial changes to the product without FDA’s permission.
There have been 227 complaints about the product in a year and a half–from the end of June 2010 until December 2011.
J&J must respond with 15 business days about how it will address the issues, or it risks facing seizure of its defective products or a fine, the agency said.
The J&J spokeswoman said that the company takes the FDA’s concerns seriously and will do whatever it takes to remedy the situation.
If you or someone you know has had a problems with these or other products, the Florida Drug Injury Lawyers at Steinger, Iscoe & Greene may be able to help you.