February 24, 2011

In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling, at the wholesale level in the U.S., nine product lots of SUDAFED® 24 Hour, Pseudoephedrine HCl, Extended – Release Tablets, 10 count, 240 mg each.

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.

No action is required by consumers or healthcare providers. Consumers can continue to use the product, which contains the proper directions on the internal blister packaging, which states "swallow each tablet whole; do not divide, crush, chew, or dissolve the tablet."

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

The LOT# for the recalled products can be found on the product side panel.

FULL RECALLED PRODUCTS LIST:

CLICK HERE TO SEE FREQUENTLY ASKED QUESTIONS

CLICK HERE FOR INFORMATION ABOUT THE PREVIOUS RECALL OF SUDAFED PE^®