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Mucotrol Concentrated Oral Gel Wafer

by Belcher Pharmaceuticals, Inc.

510(k) K042400

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK042400 Date24 Nov 2004ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0398-2007 FDA Unclassified (pre-2012) initiated 25 Sep 2006 on shared 510(k) K042400

    Processing and cleaning process validation were not completed before production. Product had some GMP failures related to the quality system.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OLR
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent