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J & J's McNeil Expands Tylenol Benadryl Recall

Posted by Jane Akre
Wednesday, June 16, 2010 4:25 PM EST
Category: Protecting Your Family
Tags: Johnson & Johnson, McNeil Healthcare, Tylenol, Benadryl, Congress, FDA

Expanded Recall

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IMAGE SOURCE: McNeil Consumer Healthcare Web site

Five months after the initial recall of Tylenol and Motrin over-the-counter (OTC) pain medications, store shelves are reported to be bare.

This latest recall will not help matters.

Johnson & Johnson (J&J) and its McNeil Consumer Healthcare division announced Tuesday it is recalling four additional lots of Benadryl allergy tablets.

In addition, one lot of Extra Strength Tylenol gels will be recalled in what the company calls an expansion of a wider recalled announced on January 15 of 53 million bottles of Tylenol, Motrin, Rolaids, Benadry,l and St. Joseph’s Aspirin.

The problem with the OTC medication is that it might have been exposed to a chemical – 2,4,6-tribromoanisole or TBA that was used to treat the wood pallets that held the packing materials at the J &J plant in Las Piedras, Puerto Rico.

The January recall was issued because of a musty odor that was determined to have come from the chemical on the pallets.

J & J’s McNeil Consumer Healthcare unit, maker of the Tylenol, Motrin, and Benadryl brands received a letter from the FDA in January concerning the musty smell and is just part of a larger quality-control problem company-wide.

Lot numbers are found on the side of the bottle label. Reimbursement requests should be made at www.mcneilproductrecall.com.

Children’s Tylenol Recall

In what appears to be a system-wide problem with production, last month McNeil issued a recall for 43 brands of Tylenol brand infant products after an FDA investigation of the manufacturing plant in Fort Washington, Pennsylvania revealed unsanitary conditions, contamination, and an inconsistent final product.

The recall was triggered by what the FDA calls “manufacturing deficiencies” that affect the quality, purity or potency of the drugs, says the FDA in a news release.

Congress is investigating and the FDA is considering criminal charges. The Fort Washington plant has been closed.

Of most concern is the “phantom” recall uncovered by a House Committee on Oversight and Government Reform, complete with a memo released last month that told secret shoppers NOT to mention their removal of Motrin from stores shelves was part of any recall.

“THERE MUST BE NO MENTION OF THIS BEING A RECALL OF THE PRODUCT,” it says.

When this activity was discovered by the FDA, J&J then announced the recall.

Committee Chairman Edolphus Towns said at the hearing, “It turns out there wasn’t just one recall. What we have heard about today is rolling recalls, a phantom recall, a plant shut down, and management firings. I was hoping that J&J would be completely forthcoming today, but I think there are still unanswered questions.”

J&J continues to maintain it is working closely with the FDA in a “transparent” way and plans to have a master plan on fixing manufacturing errors by July 15. #


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