Reese Pharmaceutical Company OTC Products Recalled because they were Mislabeled as Guaifenesin Tablets

Pharmacists and Consumers are informed by the FDA that Reese Pharmaceutical Company OTC Products are recalled because they were mislabeled as Guaifenesin tablets posing a threat of overdose to patients.

Background of Reese Pharmaceutical Company OTC Products

Refenesen Expectorant (guaifenesin 200 mg tablets), Select Brand Mucus Relief Expectorant (guaifenesin 200 mg), QC Medifin Expectorant (guaifenesin 200 mg), and Leader Cough Tabs Expectorant (guaifenesin 200 mg), by Reese Pharmaceutical Company, are cold decongestant tablets.

FDA Alert on Reese Pharmaceutical Company OTC Products

FDA’s reason for the recall is that Reese Pharmaceutical Company OTC Products:

• Refenesen Expectorant (guaifenesin 200 mg tablets),
• Select Brand Mucus Relief Expectorant (guaifenesin 200 mg),
• QC Medifin Expectorant (guaifenesin 200 mg), and
• Leader Cough Tabs Expectorant (guaifenesin 200 mg)

were mislabeled as containing only 200mg Guaifenesin tablets. The tablets contain also Acetaminophen 325 mg, Phenylephrine 5 mg & Chlorpheniramine Maleate 2 mg and this may cause overdose. Overdose of Acetaminophen can lead to liver damage. Moreover, contraindications for Phenylephrine include high blood pressure and poor blood flow to the extremities. Phenylephrine should be used with caution in patients with heart disease, diabetes and high blood pressure.

The affected lot is 091612 in 60-count size bottles.

Contacting the FDA to report cases with Reese Pharmaceutical Company OTC Products

In case of detection of adverse events or side effects related to the use of Reese Pharmaceutical Company OTC Products, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

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