Z-0398-2007

Product is Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle

Name: Z-0398-2007 Product is Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle
Creator: Belcher Pharmaceuticals Inc.
Published: 2006-09-25
License: https://open.fda.gov/license/

Belcher Pharmaceuticals, Inc. / initiated 2006-09-25 / Terminated / root cause: manufacturing process

FDA source

Belcher Pharmaceuticals Inc. began a recall of Product is Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle on 2006-09-25. The reason FDA records is "Processing and cleaning process validation were not completed before production. Product had some GMP failures related to the quality system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0398-2007
Status: Terminated
Initiated: 2006-09-25
Posted: 2007-02-07
Terminated: 2008-07-22
Recalling firm: Belcher Pharmaceuticals, Inc.
Product: Product is Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle.
Product code: FRO Dressing, Wound, Drug
Reason for recall: Processing and cleaning process validation were not completed before production. Product had some GMP failures related to the quality system.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Consignees were notified of recall via letter dated 09/25/2006.
Quantity in commerce: 1097 bottles
Distribution: Nationwide.
Product codes and lots: Batch/Lot numbers 65AB, 97AB, and 99 AB

Product code FRO

K042400UnclassifiedMucotrol Concentrated Oral Gel WaferBelcher Pharmaceuticals, Inc. / cleared 2004-11-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)