Mislabeled Mucinex recalled by manufacturer
PARSIPPANY, NJ - A New Jersey drug manufacturer has recalled certain bottles of Mucinex liquid cold and sinus remedies.
RB is recalling 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 manufacturer says that the mislabeling could cause the consumer to be unaware of side effects or risks associated with the ingestion of certain product ingredients which include Acetaminophen, Dextromethorphan, Guaifenesin, Phenylephrine and/or Diphenhydramine.
People who take the product 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.
As a precautionary measure, RB is asking consumers to dispose of any unused product in accordance with the following recommended guidance for drug disposal:
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 into the household trash.
A list of potentially impacted batches can be found by clicking on this link
Consumers who have purchased the product can contact the RB 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.
Adverse reactions or quality problems experienced with the use of the product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
