Health Team

Sudafed recalled for labeling error

Posted March 2, 2011 2:59 p.m. EST

McNeil Consumer Healthcare is recalling, at the wholesale level in the U.S., nine product lots of Sudafed 24-hour, pseudoephedrine HCl, extended-release tablets.

The company initiated the recall due to a typographical error in the directions on the label, which incorrectly repeated the word “not” when advising users against dividing, crushing, chewing or dissolving the tablet.

To date, there have been no reports of adverse events caused by the labeling error, the company said.

No action is required by consumers or health care providers. Consumers can continue to use the product, which contains the proper directions on the internal blister packaging.

Consumers with questions can call McNeil's Consumer Care Center at 1-888-222-6036 (available Monday-Friday from 8 a.m. – 8 p.m. Eastern Time).

The lot numbers involved in the recall are 1004651, 1004652, 1005870, 1005874, 1008467, 1008468, 1009532, 1010850 and 1013065. The lot numbers can be found on the side of the package.