Label typo leads to recall of J&J's Sudafed

‘Do not not divide, crush, chew, or dissolve the tablet’ label direction prompts recall of 667,632 Sudafed packages.


The February 25 Wall Street Journal Health Blog reported that a double negative regarding dosing instructions on nine lots of Sudafed 24 Hour Extended-Release packages of 10 tablets prompted a recall of 667,632 packages. The article said it was the latest in “J&J’s string of recalls, which cost it about $900 million in sales last year.” The article includes a bullet-point-style “running list” of those recalls.

On its Sudafed Web site, Johnson & Johnson notes that the company worked “in consultation with the U.S. Food and Drug Administration,” on the recall. The Web site says, “McNeil Consumer Healthcare initiated the recall at the wholesale level due to a typographical error in the Directions section on the label, which incorrectly repeated the word ‘not’ as follows: ‘do not not divide, crush, chew, or dissolve the tablet. To date there have been no reports of adverse events caused by this labeling error.’

Lot numbers for recalled products are listed, along with a “click here” link for frequently asked questions on the matter. The company says, “Consumers can continue to use the product, which contains proper directions on the internal blister packaging, which states, ‘swallow each tablet whole; do not divide, crush, chew, or dissolve the tablet.’”

Johnson & Johnson has had its share of packaging-related recalls in the past year, but the company is not alone. The FDA provides an online resource for recalls, market withdrawals, and safety alerts.

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