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U.S. Department of Health and Human Services

Class 2 Device Recall Mucotrol

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 Class 2 Device Recall Mucotrolsee related information
Date Initiated by FirmSeptember 25, 2006
Date PostedFebruary 07, 2007
Recall Status1 Terminated 3 on July 22, 2008
Recall NumberZ-0398-2007
Recall Event ID 36458
510(K)NumberK042400 
Product Classification oral protective gel wafer - Product Code FRO
ProductProduct is Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle.
Code Information Batch/Lot numbers 65AB, 97AB, and 99 AB
Recalling Firm/
Manufacturer		 Belcher Pharmaceuticals Inc.
12393 Belcher Rd.
Interlaken Commerce Ctr #420
Largo FL 33773
Manufacturer Reason
for Recall		Processing and cleaning process validation were not completed before production. Product had some GMP failures related to the quality system.
FDA Determined
Cause 2		Other
ActionConsignees were notified of recall via letter dated 09/25/2006.
Quantity in Commerce1097 bottles
DistributionNationwide.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FRO
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