Recall of Mucotrol

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Belcher Pharmaceuticals Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    oral protective gel wafer - Product Code FRO
  • Reason
    Processing and cleaning process validation were not completed before production. product had some gmp failures related to the quality system.
  • Action
    Consignees were notified of recall via letter dated 09/25/2006.



  • Manufacturer Address
    Belcher Pharmaceuticals Inc., 12393 Belcher Rd., Interlaken Commerce Ctr #420, Largo FL 33773
  • Source