Recall Z-0398-2007 ยท FRO Dressing, Wound, Drug
Belcher Pharmaceuticals Inc.
Product is Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle.
| Date | Feb 7, 2007 (initiated Sep 25, 2006) |
| Status | Terminated |
| Reason | Processing and cleaning process validation were not completed before production. Product had some GMP failures related to the quality system. |
| Root cause | Other |
| Action | Consignees were notified of recall via letter dated 09/25/2006. |
| Quantity | 1097 bottles |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042400 | MUCOTROL CONCENTRATED ORAL GEL WAFER Belcher Pharmaceuticals, Inc., Nov 24, 2004 |