Product is Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle.
FDA device recall Z-0398-2007 · posted 2007-02-07 · Terminated
Recall details
- Recalling firm
- Belcher Pharmaceuticals Inc.
- Reason for recall
- Processing and cleaning process validation were not completed before production. Product had some GMP failures related to the quality system.
- Action taken
- Consignees were notified of recall via letter dated 09/25/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRO
- Quantity affected
- 1097 bottles
- Distribution
- Nationwide.
- Date initiated
- 2006-09-25
- Date posted
- 2007-02-07
- Date terminated
- 2008-07-22
- Location
- Largo, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MUCOTROL CONCENTRATED ORAL GEL WAFER (K042400) | Belcher Pharmaceuticals, Inc. | 2004-11-24 |