RB (formerly Reckitt Benckiser) of Parsippany, NJ, has recalled certain lots of liquid bottles of Mucinex Fast-Max Night Time Cold & Flu; Mucinex Fast-Max Cold & Sinus; Mucinex Fast-Max Severe Congestion & Cough; and Mucinex Fast-Max Cold, Flu & Sore Throat. These over-the-counter medications, which correctly label the product on the front of the bottle and lists all active ingredients, may not have the correct corresponding drug facts label on the back. This recall was due to a confirmed report from a retailer.
This mislabeling could cause the consumer to be unaware of side effects and/or risks associated with the ingestion of certain product ingredients, which include Acetaminophen, Dextromethorphan, Guaifenesin, Phenylephrine, and/or Diphenhydramine. The voluntary recall is being issued nationwide as a precautionary measure to ensure consumers have all relevant facts and warnings for the active ingredients contained in the bottle.
Due to the mislabeling, consumers could take a product with unstated levels of Acetaminophen, Dextromethorphan, Guaifenesin, Phenylephrine, and/or Diphenhydramine. Consumers would not be adequately warned of side effects that could potentially lead to health complications requiring urgent medical intervention, particularly in the case of acetaminophen use in people with liver impairment, those drinking three or more alcoholic beverages, or those taking other medicines containing this active ingredient without consulting a doctor.
See the Recall
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication