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Terminated

Product is Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle.

FDA Recall Z-0398-2007 · Posted 2007-02-07

Recalling FirmBelcher Pharmaceuticals Inc.
Recall StatusTerminated
Product CodeFRO
Date Initiated2006-09-25
Date Terminated2008-07-22
Product Quantity1097 bottles

Reason for Recall

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

Firm Action

Consignees were notified of recall via letter dated 09/25/2006.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042400MUCOTROL CONCENTRATED ORAL GEL WAFERBelcher Pharmaceuticals, Inc. · 2004-11-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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