Raw materials used to make children's liquid cold medications subject to an April 30 recall were contaminated with bacteria, according to a U.S. Food and Drug Administration report released Tuesday.
The recall affected 43 different Johnson & Johnson products sold under the brand names of Tylenol, Motrin, Zyrtec and Benadryl.
Preliminary tests have only narrowed down the possible bacterial contaminant to a category of microorganism described as "gram negative," a broad group that includes many germs potentially harmful to humans. No injuries or illnesses have been reported in relation to the recalled products, and the FDA has said that despite finding the bacterial contaminants in the raw materials used to make the drugs, tests have yet to reveal any of the finished product to be similarly contaminated.
The report also suggested that raw material with "known contamination with gram negative organisms" were used to manufacture several finished lots of Children's and Infant's Tylenol drug products.
In response to the report, the McNeil Consumer Healthcare plant in Fort Washington, Pa., where the medicines were made by the Johnson & Johnson subsidiary, has been shut down by the company indefinitely. In addition to the presence of bacterial contamination in raw materials, the FDA report also cited inadequate quality-control procedures and spotty adherence to the quality-control procedures that did exist. FDA inspectors also noted dirty conditions within the plant. In total, the report made 20 observations of shortcomings at the plant.
Deborah Autor, director of FDA's drug compliance office, said during a Tuesday news teleconference that the report reflected "numerous deficiencies in the way McNeil products were manufactured."
But she said that while the agency's initial assessment of the quality shortcomings at the plant were serious, "[we] cannot yet say if further FDA action is warranted."
Dr. Richard Besser, ABC News senior health and medical editor, spoke with FDA officials who said they have been working with McNeil since May 2009 on these issues. They said that McNeil had assured them over time that they were taking sufficient action, but subsequent inspections showed otherwise.
The FDA met with Johnson & Johnson and McNeil in February to express its concerns about their production practices and was assured that the problems were being addressed.
Johnson and Johnson issued a statement Tuesday in response to the report.
"The quality issues that the FDA has observed, many of which we had recently identified in our own quality reviews and communicated to the FDA, are unacceptable to us, and not indicative of how McNeil Consumer Healthcare intends to operate," the Johnson and Johnson statement read.
Since Friday's recall, FDA officials have said that the recall was issued out of an "abundance of caution." And during a news conference Tuesday, FDA officials reiterated that the risk of illness from the recalled drugs was remote.
But drug-safety experts said that serious or not, the episode proved that not just generic drugs can fall victim to quality-control problems.
"This recall provides compelling evidence that quality assurance is an issue for all drugmakers, and is not specific to generic products, as many have implied," said Dr. Jerry Avorn, professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital.
Merrill Goozner, a freelance writer and independent consultant to consumer groups, said, "This shows that the problem isn't generic versus brand, but good manufacturing practices versus sloppy manufacturing practices. The FDA needs more money to police the entire drug manufacturing supply chain, brand name and generic, over-the-counter or prescription."
Click HERE to see the FDA's report.
The company and the FDA issued the voluntary recall of certain over-the-counter children's and infants' liquid products after consumer complaints of "tiny particles" in the medicines, as well as the possibility that some of the medications "may contain a higher concentration of active ingredient than is specified" and "others may contain inactive ingredients that may not meet internal testing requirements," according to a news release on the company's website.
The recall is the drugmaker's third in the past eight months directly related to quality problems. In December, certain arthritis medications and other products were pulled from the market after reports of an "unusual moldy, musty, or mildew-like odor" and cases of gastrointestinal illness linked to the consumption of the products.
A number of pediatric liquid products were recalled in December because of concerns over the quality of an inactive ingredient that is a component of the drugs.
"Speaking as a parent and a pharmacologist, the frequency of these recalls does not foster great confidence in the manufacturing standards for these medicines in that they are being released before quality testing is completed," said Dr. David Kroll, professor of pharmaceutical sciences at North Carolina Central University in Durham. "I was struck in particular by the comment from the FDA that parents consider substituting generic versions of the child medicines, rather than use adult-strength medicines."
Another potential problem is that the recall affects the same category of medications that came under fire from an FDA advisory committee in 2007.
"The FDA nonprescription drug advisory committee [at the time] found that there was little to no compelling evidence that cough and cold medications are efficacious in children under 6, and they may pose a meaningful risk," said Dr. William Shrank of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital and a member of the FDA OTC drug advisory panel.