Roxane Laboratories, Inc.
FDA Regulatory Profile
Roxane Laboratories, Inc. appears in FDA public data with 2 recalls, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0437-2017, Class II) was initiated on December 22, 2016. Its most recent 510(k) clearance was granted on November 16, 1982.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0437-2017 | Class II | Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohi | December 22, 2016 |
| D-0448-2017 | Class III | Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL b | December 14, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K822971 | SALIVA SUBSTITUTE | November 16, 1982 |