Athenex Pharma Solutions, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 0
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0711-2022 | Class II | Phenylephrine HCl Injection in 0.9% Sodium Chloride, 20 mg, 250 mL excel bag, Rx only, Athenex Pharm | March 14, 2022 |
| D-0712-2022 | Class II | Epinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8mg, 250 mL excel bag, Rx only, Athen | March 14, 2022 |
| D-0708-2022 | Class II | Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8 mg, 250 mL excel bag, | March 14, 2022 |
| D-0707-2022 | Class II | Norepinephrine Bitartrate Injection 16 mg per 250 mL added to 0.9% Sodium Chloride, 16 mg, 250 mL ex | March 14, 2022 |
| D-0706-2022 | Class II | Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride, 4 mg, 250 mL excel bag, | March 14, 2022 |
| D-0709-2022 | Class II | Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride, 40 mg, 250 mL excel bag, Rx on | March 14, 2022 |
| D-0710-2022 | Class II | Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride, 50 mg, 250 mL excel bag, Rx on | March 14, 2022 |