Belcher Pharmaceuticals Inc. Product is Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Product is Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle.
Brand
Belcher Pharmaceuticals Inc.
Lot Codes / Batch Numbers
Batch/Lot numbers 65AB, 97AB, and 99 AB
Products Sold
Batch/Lot numbers 65AB, 97AB, and 99 AB
Belcher Pharmaceuticals Inc. is recalling Product is Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle. due to Processing and cleaning process validation were not completed before production. Product had some GMP failures related to the quality system.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Processing and cleaning process validation were not completed before production. Product had some GMP failures related to the quality system.
Recommended Action
Per FDA guidance
Consignees were notified of recall via letter dated 09/25/2006.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026