Federal health regulators have just issued a new warning to Johnson & Johnson. This time, the company is being faulted for issues regarding O.B. Tampons and its K-Y Liquidbeads product, according to the U.S. Food & Drug Administration (FDA).
It seems, said Reuters, some 227 complaints have been received about K-Y Liquibeads, a product the FDA says Johnson & Johnson never received approval to sell and O.B. Tampons. Complaints were received from late June 2010 to December 2011.
The regulators reproached McNeil-PPC Inc., a unit of Johnson & Johnson, for never reporting and appropriately following up on complaints such as toxic shock treatment, citing a warning letter just posted on the agency’s website. Dow Jones said that, according to the FDA, the firm submitted a the toxic shock report late but did respond adequately to its concerns about that report. Also ignored were consumer complaints that the personal lubricant, K-Y Liquibeads Vaginal Moisturizer, that it would not dissolve or had an “uncharacteristic” consistency, said the FDA.
The warning letter followed an FDA inspection of the Skillman, New Jersey McNeill-PPC facility from December 12, 2011 through January 19, 2012, said Dow Jones.
The FDA said some complaints were closed with no company investigation, said Dow Jones. The FDA also said that McNeil-PPC never appropriately investigated complaints that contained an incorrect lot number.
The FDA said McNeil-PPC did not advise the agency that it intended on selling K-Y Liquibeads and that it also made significant changes to the lubricant versus prior and similar products, never receiving agency permission, said Reuters.
Johnson & Johnson has 15 business days to advise the FDA on how it will respond to the issues. Should it not, it faces a fine and product seizure, said Reuters. McNeil said it takes the issues raised by FDA seriously. “We will respond fully to their concerns and take whatever steps are needed to resolve these issues,” the company said in a statement, wrote Dow Jones.
Since September 2009, McNeil’s Consumer Healthcare unit has issued at least 25 product recalls and Johnson & Johnson and its other units have been involved in a series of recalls that involve everything from smelly Extra-Strength Tylenol caplets, sterility issues, and problems that involved 200 million bottles of medications, including the company’s Ortho-McNeil-Janssen Pharmaceuticals division’s prefilled Invega Sustenna syringe. The drug and device giant also recalled its Ethicon unit’s surgical drainage products; two hip replacement implants, sold by its DePuy Orthopaedics unit; insulin pump cartridges made by its Animas unit; 1-Day Acuvue TruEye contact lenses; and Simponi injection pens, to name just some. Johnson & Johnson is also facing some 500 lawsuits over its transvaginal mesh products.
Dow Jones mentioned that McNeil Consumer Healthcare is working to address manufacturing problems that led to recalls of Tylenol and other over-the-counter products and noted that three of the company’s manufacturing plants were placed under an FDA consent decree last year. Its Fort Washington, Pennsylvania plant still remains shut down.