News

Recall of certain lots of SUDAFED® 24 Hour - February 24, 2011

Why are you recalling these products?

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.

Which products are included in the recall?

There are nine product lots of SUDAFED® 24 Hour, Pseudoephedrine HCl, Extended – Release Tablets, 10 count, 240 mg each included in this recall. The LOT # for the recalled products can be found on the product side panel.

FULL RECALLED PRODUCTS LIST:

PRODUCT

LOT#

SUDAFED® 24 Hour, Pseudoephedrine HCl, Extended – Release Tablets, 10 count, 240 mg each

1004651, 1004652, 1005870, 1005874, 1008467, 1008468, 1009532, 1010850, 1013065

Are there any consumer safety concerns related to the reason for this recall?

No. This recall is not being undertaken on the basis of adverse events. No action is required by consumers or healthcare providers. Consumers can continue to use the product which is correctly labeled on the internal blister packaging which states "swallow each tablet whole; do not divide, crush, chew, or dissolve the tablet." Consumers with general questions should call our Consumer Care Center at 1-888-222-6036 (available Monday-Friday 8 a.m. to 8 p.m. Eastern Time).

What should consumers do if they have this product?

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

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


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