Another Recall of Smelly Tylenol Issued by Johnson & Johnson

Johnson & Johnson is recalling more musty-smelling Tylenol. The new recall from Johnson & Johnson’s McNeil Consumer Healthcare unit involves around 34,000 150-count bottles of Tylenol 8 Hour Extended Release Caplets.

The latest <"">Tylenol recall was prompted by a “small number” of consumer complaints about a musty smell, a McNeil statement said. The company said the musty smell was the result of trace amounts of chemicals called 2,4,6-tribromoanisole (TBA) and 2,4,6-trichloroanisole (TCA). The company says TBA is the result of a chemical applied to wood pallets that transport and store packaging materials. TBA has been behind other recalls of musty-smelling Tylenol in the past. However, according to a Dow Jones Newswires report, TCA has not been cited by Johnson & Johnson in prior recalls.

Johnson & Johnson also added 10 product lots (more than 717,000 bottles) of various Tylenol, Benadryl and Sudafed products to a recall of medicines at the wholesale level first announced in January. According to the company, the recall is a precautionary measure because a review of past manufacturing records found cases where equipment cleaning procedures were insufficient, or cleaning wasn’t adequately documented. Because it is a wholesale level recall, no consumer action is required.

According to a report in The New York Times, the products involved in these recalls were made at McNeil’s Fort Washington, Pennsylvania plant. As we reported earlier this month, that facility, which was temporarily closed last year because of quality issues, is named in a consent decree and won’t be able to reopen until the U.S. Food & Drug Administration (FDA) is assured that it meets quality standards. It is one of three Johnson & Johnson plants that would be subject to greater federal oversight under the consent decree.

This is just the latest in a string of recalls that have cost Johnson & Johnson more than $900 million in sales over the past year. The tally includes 20 recalls issued by its McNeil Consumer Healthcare division that have involved upwards of 200 million bottles -including children’s formulations – of Tylenol, Motrin and other over-the-counter drugs. Last month, the company’s Ortho-McNeil-Janssen Pharmaceuticals division recalled prefilled Invega Sustenna syringe. Just last week, Ethicon recalled a number of surgical drainage products because of sterility issues. Other Johnson & Johnson recalls have involved two DePuy hip replacement implants sold by its DePuy Orthopaedics unit, insulin pump cartidges made by its Animas unit, 1-Day Acuvue TruEye contact lenses, and Simponi injection pens.

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