Apotex Scientific, Inc
FDA Regulatory Profile
Apotex Scientific, Inc appears in FDA public data with 3 recalls, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-1435-2016, Class III) was initiated on January 26, 2016. Its most recent 510(k) clearance was granted on August 10, 1993.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-1435-2016 | Class III | Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex | January 26, 2016 |
| D-1436-2016 | Class III | Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex | January 26, 2016 |
| D-1437-2016 | Class III | Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by Apotex | January 26, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K932424 | ANA PROFILE I | August 10, 1993 |