Thursday, October 20, 2011

3 Decongestants Recalled in 2010

3 Decongestants Recalled in 2010

A decongestant is useful in treating symptoms of sinus infection. However, consult a doctor before using a decongestant to ensure that you take approved and safe medication. Recently, some decongestants were voluntarily recalled from the U.S. market considering customers’ safety.  This article focuses on three of these decongestants.

PediaCare Decongestant 4oz.

After consulting with the U.S. Food and Drug Administration (FDA), Blacksmith Brands, Inc. voluntarily recalled its four PediaCare products, designed for children, in May 2010. The products include PediaCare Decongestant 4oz., PediaCare Allergy and Cold 4oz, PediaCare Long Acting Cough 4oz. and PediaCare Multi-Symptom Cold 4oz. All the four products were exclusively distributed within the United States of America. McNeil Consumer Healthcare, a part of Johnson & Johnson Company, manufactured these products for Blacksmith. Recall was a precautionary measure in response to FDA’s inspection report that concluded that McNeil Consumer Healthcare Fort plant in Washington (Pennsylvania) was not following the latest production standards.

VapoSpray 4-Hour Decongestant Nasal Spray by Sinex

In June 2010, the Procter & Gamble Company (PG) recalled its VapoSpray, which was sold in the U.S. market. This voluntary recall was a precautionary measure, as the product formulation was not pursuant to the expiry date stamped on the spray package. The company offered refund or replacement coupons for recalled products. PG was selling VapoSpray as Sinex Nasal Spray in Ultra Fine Mist and spray forms before June 2009.

Over-the-Counter Cold Decongestant Tablets

Reese Pharmaceutical Company, based in Ohio, recalled lot#091612 of 60-count size bottles of cold decongestant tablets in December 2010. These tablets contained 325 mg of acetaminophen, 2 mg of chlorpheniramine maleate and 5 mg of phenylephrine. However, they were mislabeled. The faulty labels read that the tablets contain 200 mg of guaifenesin. The voluntary recall was initiated to ensure that consumers do not ingest the tablets and do not get any side effects of either of three ingredients. As faulty labels did not carry a warning that acetaminophen may damage the liver. High dose of acetaminophen can damage the liver. Chances of liver damage increase in patients who are already suffering from liver disorders.

The recalled tablets included Leader Cough Tabs Expectorant, QC Medifin Expectorant, Refenesen Expectorant and Select Brand Mucus Relief Expectorant.  The tablets were sold in the United States of America. The recall decision was taken after consulting the U.S. Food and Drug Administration.

Next time, when you buy a decongestant ensure that you do not use banned products that may aggravate your problems.


  1. Thanks for the information .
    It was really helpful to solve my confusion,

    Occupational Medicine

  2. Hello nr! I am at your disposal for any inquiere or suggestion. Regards