FDA recalls several brands of Mucinex

PARSIPPANY, New Jersey – The company the produces Mucinex 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 because the 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. The 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 our consumers have all relevant facts and warnings for the active ingredients contained in the bottle.

Consumers could take a product with undeclared levels of Acetaminophen, Dextromethorphan, Guaifenesin, Phenylephrine and/or Diphenhydramine. Consumers would not be adequately warned of side effects which could potentially lead to health complications requiring urgent medical intervention, particularly in the case of acetaminophen use in people with liver impairment, taking three or more alcoholic drinks or when taking other medicines containing this active ingredient without consulting a doctor.

Consumers are being asked to dispose of any unused product in accordance with the following recommended guidance for drug disposal in your household trash:

• Mix liquid medicines with an unpalatable substance such as kitty litter or used coffee grounds;
• Place the mixture in a container such as a sealed plastic bag; and
• Throw the container in your household trash. Consumers who have purchased this product can also contact the RB (formerly Reckitt Benckiser) MUCINEX FAST-MAX recall toll free number at 1-888-943-4215 between the hours of 8:00 a.m.- 8:00 p.m eastern standard time with any questions or to speak with a representative, and should refer to our website, www.mucinex.com/recall for the accurate related drug facts information. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

List of Potentially Impacted Batches