McNeil Consumer Healthcare has voluntarily shut down the Fort Washington plant where it produces Children's Tylenol and dozens of other recalled over-the-counter medications in response to an FDA report that said raw ingredients contaminated with bacteria had been used in some of the infants' and children's products.
The Food and Drug Administration said it had so far found no evidence of bacteria in any finished products it tested. At a news conference Tuesday afternoon, agency officials said they considered harm to children unlikely from the microorganisms or from previously identified problems with the McNeil medications, including inconsistencies in product potency and other contaminants.
"We think at this point that the risk to consumers is remote," said Deborah M. Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research. However, Autor said the inspection found "numerous deficiencies in the ways in which McNeil products were manufactured."
Late Friday, McNeil announced the voluntary recall of more than 40 versions of Tylenol, Motrin, Benadryl, and Zyrtec brand liquids and drops designed for infants and children. The company said all unexpired liquid versions of the products should be discarded.
FDA officials said parents should substitute generic versions of the medications, none of which are made by McNeil, a Johnson & Johnson subsidiary.
When McNeil announced the massive recall Friday night, it said that some of the products might contain "a higher concentration of active ingredients than is specified" or contaminants that a spokesman described as "solidified product ingredients or manufacturing residue, such as tiny metal specks."
In a statement Tuesday announcing that it had "temporarily suspended production" at the Fort Washington plant, McNeil said it recently had identified many of the same problems found by the FDA "in our own quality reviews."
"We will not restart operations until we have taken the necessary corrective actions and can assure the quality of products made there," McNeil said.
McNeil employs more than 1,200 people at its Fort Washington facility, according to Hoover's Company Records. It was not clear how many were affected by the temporary manufacturing shutdown. A company spokesman did not return calls or e-mail.
The FDA report, posted on the agency's Web site, reflects findings from inspections that took place between April 19 and Friday. Agency officials stressed that it was a preliminary document - "just a report of observations," as Autor put it.
Still, some of the FDA's 20 preliminary observations were striking.
Observation No. 2 said: "There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess."
Observation No. 11 said: "There is no written testing program designed to assess the stability characteristics of drug products."
The FDA inspection also cited apparent deficiencies in training, complaint handling, equipment maintenance, and microbial testing of drug components.
McNeil makes some nonliquid medications at the Fort Washington plant, but they are unaffected by the current recall.
The FDA inspection report, which was partly redacted before being posted online, did not identify the vendor that provided the raw materials found to have "known contamination with gram negative organisms," or identify any specific strain or strains of bacteria.
It was unclear whether the materials might have been provided to makers of other products.
"At this point, there's no reason for concern about the other products," Autor said.
FDA spokeswoman Elaine Gansz Bobo said the agency had moved swiftly after the inspection "to get all the information out" because of the widespread use of McNeil children's medications. "We're at the very initial phases of this recall, and we are fact-finding as well," she said.
The concerns raised by the FDA's inspectors weren't the first faced by McNeil. Autor said FDA officials met in February with officials of McNeil and Johnson & Johnson to discuss questions about manufacturing. "Since that time, McNeil has taken actions to improve," she said.
Autor said, "The agency's initial assessment is that the findings are serious, but we cannot yet say whether further action by FDA is warranted." If it is, she said, the agency's options could include warning letters, product seizures, or even civil or criminal penalties.
To learn more on the recall, go to www.mcneilproductrcall.com, or call 1-888-222-6036.
Contact staff writer Jeff Gelles at 215-854-2776 or email@example.com.