FDA Conducting Company-wide Investigation of McNeil Consumer Healthcare

The FDA has expanded its probe of McNeil Consumer Healthcare beyond the manufacturer's most recent recall of its children's and infants' liquid pain relief products. The agency said in a statement (1-page PDF; About PDFs) issued May 17 on its website that it is conducting a company-wide investigation of McNeil's drug manufacturing practices "to determine whether similar problems exist throughout the company and what additional steps the agency must take to ensure that these problems do not recur."

On April 30, McNeil announced it was recalling all unexpired lots of certain brand-name OTC children's and infants' liquid medications -- including more than 40 variations of Tylenol, Motrin, Zyrtec and Benadryl products -- because of manufacturing deficiencies that could affect quality, purity or potency.

In a May 1 news release, the FDA said that some of the recalled products may contain higher concentrations of active ingredients than specified, while others contain inactive ingredients that may not meet internal testing requirements. Other products may contain foreign particles.

McNeil subsequently closed the Fort Washington, Pa., facility where the recalled products were made and said it would not reopen that plant without notifying the FDA, which issued a highly critical report (17-page PDF; About PDFs) after an April inspection of that location.

The FDA already had sent McNeil a warning letter in January following an inspection of the manufacturer's facility in Puerto Rico, where the agency found "significant violations of the current good manufacturing practice regulations for finished pharmaceuticals."

Meanwhile, the House Committee on Oversight and Government Reform also is investigating McNeil's recall and will have a hearing May 27. William Weldon, chairman and CEO of Johnson & Johnson -- McNeil's parent company -- has been invited to testify.

The FDA said the potential for serious health problems with use of the affected products is remote, but the agency advised parents and caregivers to not administer the medications to their children as a precaution.

Generic versions of the products -- acetaminophen (Tylenol), ibuprofen (Motrin), cetirizine (Zyrtec) and diphenhydramine (Benadryl) -- are not affected by the recall and are considered safe to use, the FDA said

The most recent incident marks the second time this year -- and the third time in less than nine months -- that McNeil has recalled children's and infants' liquid pain relief products.

In January, McNeil recalled more than 500 lots of OTC products -- including Benadryl, Rolaids, multiple formulations of both Motrin and Children's Motrin and numerous formulations of Tylenol and Children's Tylenol -- because of chemical contamination.

That recall followed a September 2009 action, in which the manufacturer recalled more than 50 lots of its liquid children's and infants' Tylenol products because of potential bacterial contamination.