FDA Medical Device Recalls (openFDA)
Belcher Pharmaceuticals Inc.: Product is Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle.
- Recall number
- Z-0398-2007
- Recalling firm
- Belcher Pharmaceuticals Inc.
- Product
- Product is Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle.
- Status
- Terminated
- Initiated
- 2006-09-25
- Posted
- 2007-02-07
- Terminated
- 2008-07-22
- Reason
- Processing and cleaning process validation were not completed before production. Product had some GMP failures related to the quality system.
- Root cause
- Other
- Action
- Consignees were notified of recall via letter dated 09/25/2006.
- Quantity
- 1097 bottles
- Distribution
- Nationwide.
- Lot, serial or model codes
- Batch/Lot numbers 65AB, 97AB, and 99 AB
- 510(k) numbers
- ["K042400"]
- PMA numbers
- not on file
- Product code
- FRO
- Firm FEI
- 3033007964
- Firm city
- Largo
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28