Kroger Specialty Pharmacy, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 67
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0762-2018 | Class II | Stelara 90 mg/MI PFS NDC 57894-0061-03 84 days supply | April 3, 2018 |
| D-0772-2018 | Class II | Revlimid 15 mg oral cap NDC 59572-0415-21 28 days supply | April 3, 2018 |
| D-0776-2018 | Class II | Avonex 30 mcg/0.5 mL PFS Kit NDC 59627-0222-05 28 days supply | April 3, 2018 |
| D-0734-2018 | Class II | Humira Pen Sub-q Kit a.) 40 mg/0.8 mL (NDC 00074-4339-02); Humira Pen Psor Kit b.) 40 mg/0.8 mL (NDC | April 3, 2018 |
| D-0782-2018 | Class II | Gleevec 100 mg tablet NDC 00078-0401-34 30 days supply | April 3, 2018 |
| D-0750-2018 | Class II | Orkambi 200 mg/125 mg Tablets #112 NDC 51167-0809-01 28 days supply. | April 3, 2018 |
| D-0747-2018 | Class II | Botox 100 Units Vial NDC 00023-1145-01 90 days supply. | April 3, 2018 |
| D-0746-2018 | Class II | Enbrel PFS 50 mg/mL Inj #4 NDC 58406-0435-04 28 days supply; | April 3, 2018 |
| D-0741-2018 | Class II | Taltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 28 days supply | April 3, 2018 |
| D-0737-2018 | Class II | Pediasure Liq. Vanilla G+G (CAN) #24 24 days supply, NDC 70074-0558-98 | April 3, 2018 |
| D-0785-2018 | Class II | Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply | April 3, 2018 |
| D-0787-2018 | Class II | Sutent 37.5 mg capsules x28 NDC 00069-0830-38 28 days supply | April 3, 2018 |
| D-0764-2018 | Class II | Praluent 75 mg Pen (2 pens/Pkg) NDC 00024-5901-02 28 days supply | April 3, 2018 |
| D-0766-2018 | Class II | Copaxone 20 mg Injection PFS (30) NDC 68546-0317-30 30 days supply. | April 3, 2018 |
| D-0743-2018 | Class II | Altera Handset NDC 83490-0678-05 56 days supply | April 3, 2018 |
| D-0754-2018 | Class II | Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply | April 3, 2018 |
| D-0780-2018 | Class II | Temozolomide 20 mg NDC 43975-0253-05 28 days supply | April 3, 2018 |
| D-0745-2018 | Class II | Repatha 140 mg/mL Sureclick AI 2-pk NDC 55513-0760-02 28 days supply | April 3, 2018 |
| D-0797-2018 | Class II | Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply | April 3, 2018 |
| D-0760-2018 | Class II | Dupixent 300 mg/2 mL PFS #2 w/ NS NDC 00024-5914-01 28 days supply | April 3, 2018 |