Amerigen Pharmaceuticals Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 0
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0516-2019 | Class III | Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (ND | February 19, 2019 |
| D-0345-2019 | Class III | Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason Pharmaceutic | December 20, 2018 |
| D-0344-2019 | Class III | Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975 | December 20, 2018 |
| D-0249-2019 | Class III | Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (N | October 5, 2018 |