Children's Tylenol Recall

FDA uncovers quality control problems at plant responsible for manufacturing recalled children's medicines.
The CBS Evening News (5/4, story 7, 0:30, Couric) reported, "We're learning more tonight about last weekend's recall of children's medicine" manufactured by a unit of Johnson & Johnson, McNeil Consumer Healthcare. The company voluntarily "recalled 43 over the counter medications, including Tylenol [acetaminophen] and Motrin [ibuprofen] for children and infants." Now, according to a recently released federal report, "inspectors found more than 20 manufacturing problems at a Pennsylvania plant, which has been shut down," ABC World News (5/4, story 9, 0:30, Sawyer) reported.
The report, which the FDA "sent to McNeil last Friday, before the recall, said the company had used raw materials with known bacterial contamination to make certain lots of infants' and children's liquid Tylenol," the New York Times (5/5, B2, Singer) reports. "Samples of finished products tested negative for bacteria, however, and the risk to consumers was remote, agency officials said."
Stephen Byrn, "founder of Purdue University's pharmacy quality compliance program, said that...he doesn't doubt that the risk of health problems from the recalled lots is remote," USA Today (5/5, Rubin) reports. Still, the "type and scope of manufacturing problems cited by FDA inspectors make it difficult to have confidence in the plant's products."
Those other "numerous" documented deficiencies, the Los Angeles Times (5/5, Zajac) reports, included "'a failure to sufficiently investigate problems in its manufacturing and in its drugs,' failure to maintain proper testing facilities, and making changes in manufacturing processes without assuring that they would not harm consumers, said Deborah M. Autor, director of compliance in FDA's Center for Drug Evaluation and Research." For instance, McNeil "failed to investigate '46 consumer complaints regarding foreign materials, dark or black specks,' some dating to June 2009."
Last week, the unit also revealed that some of the liquid products may contain improper amounts of inactive ingredients or unusually high concentrations of active ones, according to the Wall Street Journal (5/5, Rockoff, Dooren). "The findings are serious, but we cannot say yet whether further action by the FDA is warranted," Autor stated during a conference call with the media.
The agency commenced the "10-day inspection" partly because "of problems discovered late last year at a McNeil plant in Puerto Rico," the Washington Post (5/5, Layton) reports. "In January, the FDA sent a warning letter to McNeil; in February, federal officials met with company" heads. "'We had concerns about the company's failure to investigate and correct quality problems,' Autor said."
In a "statement Tuesday, J&J called the problems discovered by the FDA 'unacceptable to us, and not indicative of how McNeil Consumer Healthcare intends to operate,'" the AP (5/5, Perrone) reports. The "company said production at the Fort Washington plant won't resume until corrective measures have been put in place."
Nevertheless, the "recall isn't likely to hurt New Brunswick, New Jersey- based J&J financially, said Linda Bannister, an analyst with Edward Jones & Co," Bloomberg News (5/5, Peterson, Tirrell) reports. But, "J&J may lose any good favor it had with the FDA as a result of the most recent action," another analyst contended.
Reuters (5/5, Richwine), the Dallas Morning News (5/4, Garcia), the Philadelphia Inquirer (5/4, Gelles), and HealthDay (5/4, Reinberg) also covered the story, as did ABC News (5/4, Childs) on its website.