Reese Pharmaceutical Company of Cleveland,
Ohio has voluntarily recalled
lot# 091612 only in 60-count size bottles identified under four different brand
names, because cold decongestant tablets (containing Acetaminophen 325 mg,
Phenylephrine 5 mg & Chlorpheniramine Maleate 2 mg) were mislabeled as
containing only 200mg Guaifenesin tablets. This mislabeling could cause a
consumer to ingest the product and unknowingly be exposed to serious side
effects of acetaminophen, phenylephrine or chlorpheniramine.
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. However, 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 # 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.
This
recall is being conducted with the knowledge of the U.S. Food and Drug
Administration. Notification of the recall has been sent to all customers who
purchased this product directly from Reese Pharmaceutical Company.
