ANI Pharmaceuticals, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 11
- 510(k) Clearances
- 0
- Inspections
- 9
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0565-2022 | Class II | Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901-10), b) 500-count bo | February 15, 2022 |
| D-0568-2022 | Class II | Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laboratories | February 15, 2022 |
| D-0564-2022 | Class II | Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b) 500-count b | February 15, 2022 |
| D-0566-2022 | Class II | Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902-10), b) 500-count bo | February 15, 2022 |
| D-0567-2022 | Class II | Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903-10), b) 500-count bo | February 15, 2022 |
| D-0044-2021 | Class III | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphe | October 9, 2020 |
| D-0047-2021 | Class III | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphe | October 9, 2020 |
| D-0046-2021 | Class III | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphe | October 9, 2020 |
| D-0043-2021 | Class III | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphe | October 9, 2020 |
| D-0048-2021 | Class III | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphe | October 9, 2020 |
| D-0045-2021 | Class III | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphe | October 9, 2020 |