Safety Alerts & Recalls

What does this mean?

This recall for Children's Nasal Decongestant Liquid was issued at a warehouse/retail level only. The FDA and the manufacturer have determined that any recalled product that may have reached patients does not pose a significant health risk. However, if you have Children's Nasal Decongestant Liquid made by Rugby Laboratories from lot 7D04, 7H04, 8C11, or 8F04, you may wish to ask your pharmacist to recommend a device to measure the dose - or you can throw away the product to avoid giving an incorrect dose.

If you have any concerns about this alert or the use of any pseudoephedrine product, you should consult with your physician or pharmacist.

Rugby Laboratories Recalls Select Lots of Children's Nasal Decongestant Liquid

Rugby Laboratories is recalling select lots of Children's Nasal Decongestant Liquid (Pseudoephedrine HCl), 30 mg, 4 FL oz (118 mL) bottle sold over-the-counter (OTC). Lots 7D04, 7H04, 8C11, and 8F04 are being recalled because the dosing cup provided with the product does not measure the correct dose stated in the dosing instructions.

Children's Nasal Decongestant Liquid contains the active ingredient pseudoephedrine and is used in the treatment of nasal congestion. There are many brands of pseudoephedrine and several different formulations available, including tablets and solutions. This recall alert only applies to the select lots of Children's Nasal Decongestant Liquid (Pseudoephedrine HCl), 30 mg, 4 FL oz bottles made by Rugby Laboratories. No other pseudoephedrine products were involved in this recall.

To view the FDA notice about this recall, please visit: more information here

Source: FDA
Publication Date: 2010-03-31
Last Updated: 2010-04-01

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