Kroger Specialty Pharmacy, Inc.

FDA Regulatory Profile

Summary

Total Recalls
67
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0763-2018Class IICimzia 200 mg/mL PFS Kit #2 NDC 50474-0710-79 28 days supply.April 3, 2018
D-0759-2018Class IIVosevi 400/100/100 mg Tablets #28 NDC 61958-2401-01 28 days supply.April 3, 2018
D-0748-2018Class IIProlia 60 mg/1 mL PF syringe NDC 55513-0710-01 180 days supply.April 3, 2018
D-0757-2018Class IISodium Chloride 3% Inh. 4 mL NEP #30 NDC 00487-9003-60 30 days supply.April 3, 2018
D-0762-2018Class IIStelara 90 mg/MI PFS NDC 57894-0061-03 84 days supplyApril 3, 2018
D-0777-2018Class IIIbrance 125 mg cap NDC 00069-0189-21 28 days supplyApril 3, 2018
D-0734-2018Class IIHumira Pen Sub-q Kit a.) 40 mg/0.8 mL (NDC 00074-4339-02); Humira Pen Psor Kit b.) 40 mg/0.8 mL (NDCApril 3, 2018
D-0743-2018Class IIAltera Handset NDC 83490-0678-05 56 days supplyApril 3, 2018
D-0776-2018Class IIAvonex 30 mcg/0.5 mL PFS Kit NDC 59627-0222-05 28 days supplyApril 3, 2018
D-0742-2018Class IICosentyx 150 mg/mL PFS 300 mg Dose NDC 00078-0639-98, 28 days supplyApril 3, 2018
D-0750-2018Class IIOrkambi 200 mg/125 mg Tablets #112 NDC 51167-0809-01 28 days supply.April 3, 2018
D-0746-2018Class IIEnbrel PFS 50 mg/mL Inj #4 NDC 58406-0435-04 28 days supply;April 3, 2018
D-0788-2018Class IISutent 50 mg capsules x28 NDC 00069-0550-38 42 days supplyApril 3, 2018
D-0784-2018Class IISprycel 100 mg tablet NDC 00003-0852-22 30 days supplyApril 3, 2018
D-0749-2018Class IIKitabis Pak 300 mg/5 mL Soln PARI #56 NDC 24492-0850-56 56 days supplyApril 3, 2018
D-0761-2018Class IIBoost VHC Oral Liquid VAN #27 NDC 43900-0182-15 27 days supplyApril 3, 2018
D-0737-2018Class IIPediasure Liq. Vanilla G+G (CAN) #24 24 days supply, NDC 70074-0558-98April 3, 2018
D-0789-2018Class IIImatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supplyApril 3, 2018
D-0741-2018Class IITaltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 28 days supplyApril 3, 2018
D-0797-2018Class IITasigna Capsules 150 mg NDC 00078-0592-87 28 days supplyApril 3, 2018