McNeil Consumer Healthcare Division Recalls Sudafed Lots

McNeil Consumer Healthcare Division of McNeil-PPC Inc. is reporting on its Web site that the company is recalling nine product lots of Sudafed 24-Hour, Pseudoephedrine HCl, Extended-Release Tablets, 10 count, 240 mg each. The recall is being conducted in consultation with FDA, read the notice dated February 24, 2011.

The reason for the recall is a typographical error under the Directions section on the label: an extra "not."

“Do not not divide, crush, chew, or dissolve the tablet,” reads the label. Correctly printed directions are found on the blister packaging, which reads “swallow each tablet whole; do not divide, crush, chew, or dissolve the tablet.”

McNeil reports that it is unaware of any reports of adverse events caused by this labeling error.

Following are the affected lots: 1004651, 1004652, 1005870, 1005874, 1008467, 1008468, 1009532, 1010850, and 1013065.

In January, McNeil recalled lots of Sudafed PE after a review of past production records at its Fort Washington, PA, plant "found instances where equipment cleaning procedures were insufficient or that cleaning was not adequately documented," the company stated.