Safety Alerts & Recalls

What does this mean?

To date, there have been no reports of adverse events from use of these recalled products. However, taking this mislabeled product could unknowingly expose consumers to side effects of acetaminophen, phenylephrine or chlorpheniramine and this alert should be taken seriously. Please check your medicine cabinet to see if you have any of the recalled product. If you have purchased the recalled product (lot # 091612 only), you should contact Russ or Neal Slaby at 1.800.321.7178 between 7:30-4:00pm eastern standard time for return instructions, medical information, questions, complaints or assistance.

If you think you are experiencing side effects or have other medical concerns, you should contact your healthcare provider.

Any adverse reactions may also be reported to the FDA's MedWatch Adverse Event Reporting Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Reese Pharmaceutical Company Recalls Certain Over-The-Counter Cold Relief Products That Are Mislabeled

Reese Pharmaceutical Company has voluntarily recalled four different brand name cold products containing Guaifenesin 200 mg tablets. Specifically, 60-count size bottles from lot number 091612 were mislabeled and do not contain a complete listing of all ingredients. The mislabeled product contains Acetaminophen 325 mg, Phenylephrine 5 mg, and Chlorpheniramine Maleate 2 mg in addition to Guaifenesin 200 mg. This mislabeling could cause a consumer to ingest the product and unknowingly be exposed to serious side effects of acetaminophen, phenylephrine or chlorpheniramine.

The four different brand names with their product NDC numbers include: Refenesen Expectorant (guaifenesin 200 mg tablets) NDC 10956-752-60

Select Brand Mucus Relief Expectorant (guaifenesin 200 mg) NDC 15127-129-60

QC Medifin Expectorant (guaifenesin 200 mg) NDC 63868-754-60

Leader Cough Tabs Expectorant (guaifenesin 200 mg) NDC 37205-466-72

The mislabeled product does not warn consumers that ingesting high doses of acetaminophen can potentially cause severe liver damage, especially among consumers with pre-existing liver disease and those who drink three or more alcoholic drinks per day. Overdose is more likely to occur if consumers are also taking other cold/cough products that contain acetaminophen in addition to the mislabeled product.

Phenylephrine should be avoided in patients with high-blood pressure, poor blood flow to the extremities, and patients on antidepressants known as MAO Inhibitors. 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.

For more information, please visit: more information here

Source: Manufacturer
Publication Date: 2010-12-13
Last Updated: 2010-12-13

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