U.S. drug regulators chided a Johnson & Johnson unit for not reporting or investigating customer complaints about O.B. Tampons or personal lubricants similar to K-Y Jelly.
The Food and Drug Administration said the unit, McNeil-PPC Inc, did not properly follow up on complaints that included toxic shock syndrome from using the tampon, according to a warning letter posted on the FDA's website on Tuesday.
The company also did not investigate some complaints about the personal lubricant K-Y Liquibeads Vaginal Moisturizer, which in fact it never got permission to sell, the FDA said in the letter dated May 22.
J&J has recalled hundreds of millions of bottles and packages of its over-the-counter medicines in the past few years, such as the painkillers Tylenol and Motrin, due to quality lapses at its factories.
The FDA said McNeil-PPC never told regulators it planned to sell the K-Y Liquibeads, and made substantial changes to the lubricant compared with previous, similar products without getting permission to do so.
The company received 227 complaints about the product from the end of June 2010 until December 2011, including the fact the lubricant did not dissolve or had "uncharacteristic" consistency, the FDA said.
The agency said J&J must respond within 15 business days about how it will address the issues, or risk facing seizure of its products or a fine.
J&J spokeswoman Jodie Wertheim said McNeil PPC takes the FDA's concerns seriously and will do whatever is necessary to resolve the issues.
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