Safety Alerts & Recalls

What does this mean?

McNeil has determined that the risk of serious injury in someone taking the recalled product is low and has recalled these medicines at the warehouse level only. 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.”

If you have general questions about this recall, you can call the McNeil Consumer Care Center at 1-888-222-6036 (available Monday-Friday from 8 a.m. – 8 p.m. Eastern Time). If you have medical concerns about Sudafed or any pseudoephedrine product, please contact your doctor or other healthcare provider.

Recall of Certain Lots of SUDAFED 24 Hour

McNeil Consumer Healthcare has issued a recall in the U.S. of nine product lots of SUDAFED 24 Hour, Pseudoephedrine HCl, Extended - Release Tablets, 10 count, 240 mg because of a printing 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.

The following lot numbers are being recalled: SUDAFED 24 Hour, Pseudoephedrine HCl, Extended – Release Tablets, 10 count, 240 mg each: 1004651, 1004652, 1005870, 1005874, 1008467, 1008468, 1009532, 1010850, 1013065

The lot number for the recalled products can be found on the product side panel.

Sudafed 24 Hour contains the active ingredient pseudoephedrine and is use in the treatment of nasal congestion. Pseudeophedrine is sold under several brand names, strengths, and formulations. This recall only affects the nine lots of SUDAFED 24 Hour, Pseudoephedrine HCl, Extended – Release Tablets, 10 count, 240 mg each. No other products were involved in this recall.

For more information, please visit: more information here

Source: Manufacturer
Publication Date: 2011-02-25
Last Updated: 2011-02-25

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