OTC Cold Meds Recalled By Reese Pharmaceutical, Are Mislabled

<"http://www.yourlawyer.com/practice_areas/defective_drugs">Over-the-counter (OTC) cold medicines are being recalled by Reese Pharmaceutical Company of Cleveland, Ohio. According to a recall notice posted on the Food & Drug Administration (FDA) website, Reese has voluntarily recalled lot number 091612 in its 60-count size bottles identified with fewer than four different brand names.

The cold decongestant tablets (containing Acetaminophen 325 mg, Phenylephrine 5 mg, and Chlorpheniramine Maleate 2 mg) were mislabeled as containing only 200 mg Guaifenesin. This mislabeling could cause a consumer to ingest the product and unknowingly be exposed to serious side effects of acetaminophen, phenylephrine, or chlorpheniramine.

Following is a breakdown of the recalled medications:

• Refenesen Expectorant (guaifenesin 200 mg tablets): NDC Number 10956-752-60; Lot Number 091612 05/11 SS/SCT36 06/26/09.

• Select Brand Mucus Relief Expectorant (guaifenesin 200 mg): NDC Number 15127-129-60; Lot Number 091612 05/11 SS/SCT36 06/26/09.

• QC Medifin Expectorant (guaifenesin 200 mg): NDC Number 63868-754-60; Lot Number 091612 05/11 SS/SCT36 06/26/09.

• Leader Cough Tabs Expectorant (guaifenesin 200 mg): NDC Number 37205-466-72; Lot Number 091612 05/11 SS/SCT36 06/26/09.

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 allergic to any of the ingredients or with narrow angle glaucoma, or who are pregnant or nursing mothers, also should not take the product. To date, there have been no reports of adverse events from its use.

This product was distributed nationwide. Consumers who have purchased the product (lot number 091612 only) 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. Notification was sent to all customers who purchased this product directly from Reese Pharmaceutical Company.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax: Online:http://www.fda.gov/MedWatch/report.htm; by regular mail, use postage-paid, pre-addressed Form FDA 3500 available here. They should be mailed to the address on the pre-addressed form; or send the form, by fax to 1-800-FDA-0178.

This entry was posted in Defective Products, Pharmaceuticals, Product Recalls, Recalled Drugs. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.