Belcher Pharmaceuticals, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Belcher Pharmaceuticals, Inc. makes
Belcher Pharmaceuticals, Inc. manufactures MUCOTROL Concentrated Oral Gel Wafer, a medication formulation designed for oral administration to manage mucus-related conditions.
This product is classified as a Class II medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Mucotrol Concentrated Oral Gel Wafer Ref K042400
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Belcher Pharmaceuticals, Inc., initiated on 2006-09-25. By recorded status: 1 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2006
- 25 Sep 2006 Z-0398-2007 Unclassified (pre-2012) Terminated Processing and cleaning process validation were not completed before production. Product had some GMP failures related to the quality system.
Frequently asked questions
How many devices does Belcher Pharmaceuticals, Inc. have in the registry?
The registry currently lists 1 device for Belcher Pharmaceuticals, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Belcher Pharmaceuticals, Inc.'s devices?
Among its 1 most recently registered device, Belcher Pharmaceuticals, Inc. has devices listed in FDA 510(k) (1 device).
Are there FDA recall records for Belcher Pharmaceuticals, Inc.?
FDA recall records list 1 recall initiated by Belcher Pharmaceuticals, Inc., the most recent initiated on 25 Sep 2006. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Belcher Pharmaceuticals, Inc. in the registry?
The most recently registered devices listed for Belcher Pharmaceuticals, Inc. include MUCOTROL CONCENTRATED ORAL GEL WAFER.