Recalls

Mislabeled OTC cough, cold and congestion pills recalled

Cough, cold and congestion tablets sold over-the-counter nationwide are being recalled by the manufacturer because the medicines were mislabeled. Bottles of Refenesen Expectorant, Select Brand Mucus Relief Expectorant, QC Medifin Expectorant and Leader Cough Tabs Expectorant, all of which contain 200 mg of the active ingredient guaifenesin, an expectorant. The recalled medicines also contain 325 mg acetaminophen, 5 mg phenylephrine, and 2 mg chlorpheniramine maleate, but the labels say the pills only contain 200 mg guaifenesin.

If consumers take the mislabeled medicines with other products containing acetaminophen, phenylephrine and/or chlorpheniramine, they could be at risk for overdose, which can lead to potentially serious health consequences. 

The mislabeled bottles do not warn consumers that acetaminophen may cause liver damage, and ingesting high levels of acetaminophen can cause severe liver damage. Consumers with pre-existing liver disease and those who drink three or more alcoholic drinks per day are at greater risk of liver damage.

People with poor blood flow to the extremities and those who take antidepressants known as MAO inhibitors should not take phenylephrine. Phenylephrine should only be taken with caution among those with high blood pressure, diabetes, heart disease, increased intraocular pressure, hyperthyroidism, or enlarged prostate. People who are allergic to any of the ingredients or who have narrow angle glaucoma, or who are pregnant or nursing mothers, also should not take the product.

The recall includes only the following products and lot numbers:

  • Refenesen Expectorant (guaifenesin 200 mg tablets), NDC# 10956-752-60; Lot # 091612 05/11 SS/SCT36 06/26/09
  • Select Brand Mucus Relief Expectorant (guaifenesin 200 mg), NDC# 15127-129-60, Lot # 091612 05/11 SS/SCT36 06/26/09
  • QC Medifin Expectorant (guaifenesin 200 mg), NDC# 63868-754-60, Lot # 091612 05/11 SS/SCT36 06/26/09
  • Leader Cough Tabs Expectorant (guaifenesin 200 mg), NDC# 37205-466-72, Lot # 091612 05/11 SS/SCT36 06/26/09

Consumers who have purchased the product (lot # 091612 only) should contact Russ or Neal Slaby at 1-800-321-7178 between 7:30-4:00 pm eastern standard time for return instructions, medical information, questions, complaints or assistance.

Consumers and health care professionals should report any side effects related to these products to the Food and Drug Administration MedWatch Adverse Event Reporting Program at www.FDA.gov/Medwatch