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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 Mucotrol see related information
Date Initiated by Firm September 25, 2006
Date Posted February 07, 2007
Recall Status1 Terminated 3 on July 22, 2008
Recall Number Z-0398-2007
Recall Event ID 36458
510(K)Number K042400  
Product Classification oral protective gel wafer - Product Code FRO
Product Product 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
Action Consignees were notified of recall via letter dated 09/25/2006.
Quantity in Commerce 1097 bottles
Distribution Nationwide.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FRO and Original Applicant = BELCHER PHARMACEUTICALS, INC.
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