Device recall
Z-0398-2007: Product is Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle.
FDA device recall · Class II · Belcher Pharmaceuticals Inc.
Key facts
| Recall number (Z-number) | Z-0398-2007 |
|---|---|
| Recall event | 36458 |
| Product | Product is Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle. |
| Product code | FRO |
| Recalling firm | Belcher Pharmaceuticals Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 22, 2008 |
| 510(k) numbers | K042400 |
| FEI number | 3033007964 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database