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-0763-2018 | Class II | Cimzia 200 mg/mL PFS Kit #2 NDC 50474-0710-79 28 days supply. | April 3, 2018 |
| D-0779-2018 | Class II | Xalkori 250 mg cap NDC 00069-8140-20 30 days supply | April 3, 2018 |
| D-0757-2018 | Class II | Sodium Chloride 3% Inh. 4 mL NEP #30 NDC 00487-9003-60 30 days supply. | April 3, 2018 |
| D-0777-2018 | Class II | Ibrance 125 mg cap NDC 00069-0189-21 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-0748-2018 | Class II | Prolia 60 mg/1 mL PF syringe NDC 55513-0710-01 180 days supply. | April 3, 2018 |
| D-0782-2018 | Class II | Gleevec 100 mg tablet NDC 00078-0401-34 30 days supply | April 3, 2018 |
| D-0784-2018 | Class II | Sprycel 100 mg tablet NDC 00003-0852-22 30 days supply | April 3, 2018 |
| D-0749-2018 | Class II | Kitabis Pak 300 mg/5 mL Soln PARI #56 NDC 24492-0850-56 56 days supply | April 3, 2018 |
| D-0738-2018 | Class II | Polyethylene Glycol 3350, powder, for solution 527g BRE, Rx Only, 28 days supply, NDC 51991-0457-57 | April 3, 2018 |
| D-0751-2018 | Class II | Orkambi 100 mg/125 mg Tablets #112 NDC 51167-0700-02 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-0773-2018 | Class II | Revlimid 20 mg oral cap NDC 59572-0420-21 28 days supply | April 3, 2018 |
| D-0789-2018 | Class II | Imatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supply | April 3, 2018 |
| D-0771-2018 | Class II | Revlimid 10 mg oral cap NDC 59572-0410-28 28 days supply | April 3, 2018 |
| D-0756-2018 | Class II | MVW Complete Softgels NDC 58204-0004-00 30 days supply; MVW Complete Chew Vitamin Grape NDC 58204-00 | April 3, 2018 |
| D-0765-2018 | Class II | Copaxone 40 mg Injection (12) NDC 68546-0325-12 28 days supply. | April 3, 2018 |
| D-0785-2018 | Class II | Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply | April 3, 2018 |
| D-0744-2018 | Class II | Cayston 75 mg Inh. Soln. SDV NDC 61958-0901-01 56 days supply | April 3, 2018 |
| D-0797-2018 | Class II | Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply | April 3, 2018 |