Reese Pharmaceutical Company OTC Products: Recall - Mislabeled Guaifenesin Tablets

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Reese Pharmaceutical Company OTC Products: Recall - Mislabeled Guaifenesin

Tablets

Refenesen Expectorant (guaifenesin 200 mg tablets)

Select Brand Mucus Relief Expectorant (guaifenesin 200 mg)

QC Medifin Expectorant (guaifenesin 200 mg)

Leader Cough Tabs Expectorant (guaifenesin 200 mg)

AUDIENCE: Consumer, Pharmacist

ISSUE: Reese Pharmaceutical Company has voluntarily recalled lot# 091612 only in

60-count size bottles identified under four different brand names: 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) because cold decongestant tablets

(containing Acetaminophen 325 mg, Phenylephrine 5 mg & Chlorpheniramine Maleate

2 mg) were mislabeled as containing only 200mg Guaifenesin tablets.

BACKGROUND: The mislabeled product does not warn consumers that Acetaminophen

may cause liver damage. Ingesting high doses of Acetaminophen can potentially

cause severe liver damage. The likelihood of acute liver damage is higher among

consumers with pre-existing liver disease and those who drink three or more

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. Contraindications for Phenylephrine are high-blood pressure,

poor blood flow to the extremities, and patients on antidepressants known as MAO

Inhibitors. Furthermore, products that contain Phenylephrine should be used with

caution in patients with high blood pressure, 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.

RECOMMENDATION: Healthcare professionals and patients are encouraged to report

adverse events or side effects related to the use of these products to the FDA's

MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete

and return to the address on the pre-addressed form, or submit by fax to

1-800-FDA-0178

Read the MedWatch safety alert, including a link to the company Press Release,

at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedical\

Products/ucm236593.htm