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New recalled Tylenol linked to shut plant

By Parija Kavilanz, senior writer

NEW YORK (CNNMoney.com) -- The adult Tylenol that was recalled this week was made at the same shuttered Fort Washington plant that produced all of Johnson & Johnson's problematic children's Tylenol medicines, CNNMoney confirmed Tuesday.

On Monday, Johnson & Johnson's (JNJ, Fortune 500) McNeil drugmaking unit announced a new recall of 127,728 bottles of Tylenol 8 Hour caplets 50 count bottles after receiving comsumer complaints of a "musty," "moldy" odor.

The company said the odor was potentially caused by the presence of a chemical called 2,4,6-tribromoanisole.

Earlier this year, McNeil recalled several lots of Tylenol drugs for the same problem. Those drugs were manufactured at its Puerto Rico facility. The company said at the time that the chemical, which is applied to wooden pallets used to transport and store packaging materials, somehow leached into the products.

Referring to the latest recall, McNeil spokesman Marc Boston said there were a small number of "adverse events" but that "none of them [were] serious." Boston said that only one of the reports was associated with the odor but declined to specify what problems were associated with the other adverse events.

Boston said it is not [yet] known whether the adverse events tied to the latest recall "are related to the presence of TBA."

Adverse events are consumer complaints of a side effect associated with the use of a medical product, according to the Food and Drug Administration.

Adverse events could range from non-serious to very serious, including death, hospitalization, disability and other health complications.

The newly recalled products were manufactured this past March.

McNeil said it has recalled the drug as a precaution and that the risk of adverse medical events was remote.

A checkered past. McNeil shut its Fort Washington, PA facility in early May after the FDA issued a scathing inspection of the plant that cited multiple manufacturing violations.

It is the company's only facility that produced non-prescription liquid pediatric pain and cold medicines. McNeil said it also made some adult products at the facility but did not disclose the specific products.

The plant shutdown also occurred just days after McNeil recalled some 50 children's versions of Tylenol, Motrin and Benadryl drugs because they may have contained small metal parts and other quality concerns.

On Tuesday, Johnson & Johnson told analysts that the company had temporarily shifted production of the children's drugs to a plant it operates in Canada. The company said the Fort Washington plant could possible reopen late next year.

For its part, the FDA said its own investigation into product quality issues with McNeil products is ongoing.

The agency also said it does not currently have access to the consumer complaints that were filed with McNeil regarding the latest recalled Tylenol product.

The recalled products are from lot number: BCM 155.

The FDA is advising that consumers check the lot number if they suspect they have the recalled product led Tylenol, stop using any affected product and consult their healthcare professional for any medical concerns.

The agency also said consumers should report any adverse events to FDA.  To top of page

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