Mislabeling Leads to Recall of Leader, Select and Other Reese Cold Medicines

 Several brands of over-the-counter cold medicine distributed by Reese Pharmaceutical Company have been recalled because the labels fail to include all of the active ingredients. 

The cold medicine recall was announced on Monday by the FDA. The products do not warn consumers that they contain several pharmaceutical ingredients, such as acetaminophen, the active ingredient in Tylenol.

The pills contain 325 mg of acetaminophen, 5 mg of Phenylephrine and 2 mg of chlorpheniramine maleate. Of chief concern is the acetaminophen, which can cause severe liver damage when ingested in high doses. Consumers suffering from colds may be taking other drugs that also contain acetaminophen and may accidentally overdose.

The recall affects 60-count bottles of pills of Refenesen Expectorant, Select Brand Mucus Relief Expectorant, QC Medifin Expectorant and Leader Cough Tabs Expectorant. All of the recalled products have a lot number of 091612. All are labeled as having an active ingredient of 200 mg of guaifenesin.

In May 2009, the FDA issued a report calling for stronger warnings on all drugs containing acetaminophen, due to the potential risk of liver damage. Aceteminophen or Tylenol overdoses are a leading cause of acute liver injury in the United States, resulting in 56,000 emergency room visits, 26,000 hospitalizations and over 450 deaths annually between 1990 and 2001.

Drugs containing acetaminophen are used by millions of Americans, both adults and children, for pain relief and to reduce fevers and combat cold and flu symptoms.

In addition to the acetaminophen concerns, phenylephrine is contraindicated for people with high-blood pressure, poor blood flow to the extremities, and patients who are taking antidepressants classified as MAO Inhibitors. People who suffer from diabetes, heart disease, increased intraocular pressure, hyperthyroidism or an enlarged prostate should also be aware that they are taking phenylephrine and use caution.

The FDA also warns that the recalled pills should not be taken by anyone with narrow angle glaucoma, pregnant women or women who are nursing.

The drugs were distributed nationwide. Any consumers who purchased the affected products should call 1-800-321-7178.