FDA (Drugs) recall action 79748
The FDA (Drugs) publishes a recall like this one as 67 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 67 pages.
Lack of Processing Controls.
The agency’s own wording, quoted from the enforcement report.
Kroger Specialty Pharmacy is recalling Bendeka 25 mg/mL 4 mL MDVPF due to a lack of processing controls. The affected product was dispensed in five states between December 2017 and February 2018.
Kroger Specialty Pharmacy is recalling Pediasure Liquid Vanilla G+G in several states due to a lack of processing controls.
Kroger Specialty Pharmacy is recalling Taltz 80 mg/mL pens distributed in five states due to a lack of processing controls.
Kroger Specialty Pharmacy is recalling Creon DR 24,000 Units capsules due to a lack of processing controls. The affected products were dispensed in five states.
Kroger Specialty Pharmacy is recalling Copaxone 20 mg Injection PFS due to a lack of processing controls. The affected lots were dispensed between December 2017 and February 2018 in five states.
Kroger Specialty Pharmacy is recalling Sprycel 80 mg tablets dispensed in five states due to a lack of processing controls.
Kroger Specialty Pharmacy is recalling Pomalyst 3 mg capsules dispensed in five states due to a lack of processing controls.
Kroger Specialty Pharmacy is recalling Polyethylene Glycol 3350 powder for solution due to a lack of processing controls. The product was distributed in five states.
Kroger Specialty Pharmacy is recalling Humira Pen Sub-q and Psor Kits due to a lack of processing controls. The affected products were dispensed in five states between December 2017 and February 2018.
Kroger Specialty Pharmacy is recalling Sutent 50 mg capsules due to a lack of processing controls. The affected products were dispensed in five states between December 2017 and February 2018.
Kroger Specialty Pharmacy is recalling Xolair 150 mg SDV due to a lack of processing controls. The affected products were dispensed in five states.
Kroger Specialty Pharmacy is recalling MVW Complete Softgels and Chew Vitamins due to a lack of processing controls.
Kroger Specialty Pharmacy is recalling Dupixent 300 mg/2 mL prefilled syringes due to a lack of processing controls. The recall affects units dispensed in five states between December 2017 and February 2018.
Kroger Specialty Pharmacy is recalling Letrozole 2.5 mg tablets dispensed between December 2017 and February 2018 due to a lack of processing controls.
Kroger Specialty Pharmacy is recalling Xalkori 250 mg capsules due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.
Kroger Specialty Pharmacy is recalling Glatiramer Acetate 40 mg/mL due to a lack of processing controls. The affected product was dispensed in five states.
Kroger Specialty Pharmacy is recalling Ibrance 125 mg capsules due to a lack of processing controls. The recall covers units dispensed in five states between December 2017 and February 2018.
Kroger Specialty Pharmacy is recalling Temozolomide 250 mg capsules due to a lack of processing controls. The recall affects specific lots dispensed between December 2017 and February 2018.
Kroger Specialty Pharmacy is recalling Sprycel 100 mg tablets because of a lack of processing controls. The affected product was distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida.
Kroger Specialty Pharmacy is recalling Vosevi 400/100/100 mg tablets due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.
Kroger Specialty Pharmacy is recalling Gleevec 100 mg tablets dispensed in five states due to a lack of processing controls.
Kroger Specialty Pharmacy is recalling Capecitabine 500 mg tablets due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.
Kroger Specialty Pharmacy is recalling Kalydeco 150 mg tablets dispensed in five states due to a lack of processing controls.
Kroger Specialty Pharmacy is recalling Azithromycin 250 mg tablets due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.
Kroger Specialty Pharmacy is recalling Pulmicort Respules 0.5 mg/2mL due to a lack of processing controls. The affected units were dispensed in five states between December 2017 and February 2018.