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J&J Hit With More Recalls

McNeil Consumer Healthcare has added five more product lots to its recall list.

The latest includes four lots of Benedryl Allergy Ultratab tablets sold in the United States and one lot of Extra Strength Tylenol rapid-release gels, sold in the United States, Trinidad, Tobago, Bermuda, and Puerto Rico.

This recall is a follow-up to the company's January 15 recall, from which these products were inadvertently omitted.

The January 15 recall was initiated in response to consumer complaints of a musty or moldy odor that has since been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). After a thorough investigation, it was determined that the presence of TBA was the result of a breakdown of a chemical that is applied to wood used to build wooden pallets that transport and store product packaging materials.

From the FDA site:

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling five product lots as an addition to the list of products included in the company?s January 15th, 2010 product recall. The additional lots involved are four product lots of BENADRYL® ALLERGY ULTRATAB? TABLETS, 100 count, sold in the U.S.; and one product lot of EXTRA STRENGTH TYLENOL® Rapid Release Gels, 50 count sold in the U.S., Trinidad and Tobago, Bermuda, and Puerto Rico (FULL RECALLED PRODUCT LIST BELOW).

This recall is a follow-up to the product recall that McNeil Consumer Healthcare announced on January 15th, 2010 and is being taken because the products were inadvertently omitted from the initial recall action. McNeil Consumer Healthcare identified the omission and informed the U.S. Food and Drug Administration (FDA) of its decision to add these product lots to the recall list. All these products were produced before the January 15th, 2010 recall. Since January, McNeil Consumer Healthcare has continued to analyze and evaluate 2,4,6-tribromoanisole (TBA) and has shared that information with the FDA. This further analysis confirms that the risk of serious adverse medical events is remote. This recall is being conducted with the knowledge of the FDA.

BENADRYL® ALLERGY ULTRATAB? TABLETS is sold over-the-counter and is indicated for the relief of allergy associated symptoms such as sneezing, runny nose, itchy throat, and itchy and watery eyes. EXTRA STRENGTH TYLENOL® Rapid Release Gels is sold over-the-counter and is indicated for the temporary reduction of fever and for the temporary relief of minor aches and pains due to headache, muscular aches, backache, minor arthritis pain, the common cold, toothache, pre-menstrual and menstrual cramps, and flu.

Full post as published by A Georgia Lawyer on June 22, 2010 (boomark / email).