December 13, 2010
Reese Pharmaceuticals recalls mislabeled guaifenesin productsReese Pharmaceuticals announced a voluntary recall of 60-count sized bottles of guaifenesin 200mg tablets from Lot# 091612 sold under four different brand names: Refenesen Expectorant, Select Brand Mucus Relief Expectorant, QC Medifin Expectorant, and Leader Cough Tabs Expectorant because cold decongestant tablets (containing acetaminophen 325mg, phenylephrine 5mg and chlorpheniramine maleate 2mg) were mislabeled as containing only 200mg guaifenesin tablets.
The mislabeled products do not warn consumers that acetaminophen may cause liver damage. The likelihood of acute liver damage is higher among consumers with pre-existing liver disease and those who drink ≥3 alcoholic drinks per day. Overdose may specially occur if consumers are also taking other cold/cough products that contain acetaminophen in addition to the mislabeled product. Furthermore, products that contain phenylephrine should be used with caution in patients with hypertension, diabetes, heart disease, increased intraocular pressure, hyperthyroidism, or enlarged prostate. Consumers who are allergic to any of the ingredients or who have narrow angle glaucoma, or are pregnant or nursing mothers, also should not take the product.
For more information call (800) 321-7178 or visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm236593.htm.