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 one lot of Imatinib Mesylate 400 mg tablets because the product lacked required processing controls.
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 Altera Handset due to a lack of processing controls. The product was distributed in five states.
Kroger Specialty Pharmacy is recalling Sodium Chloride 3% Inhalation Solution due to a lack of processing controls. The product was distributed in five states.
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 Praluent 75 mg pens due to a lack of processing controls. The affected units were dispensed in five states between December 2017 and February 2018.
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 Sutent 37.5 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 Lupron Depot 22.5 mg 3 month Kits due to a lack of processing controls. The recall affects lots dispensed in MS, LA, AR, IL, and FL 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 Zarxio 300 mcg/0.5 mL PFS due to lack of processing controls. The recall affects specific lots dispensed 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 Sprycel 80 mg tablets dispensed in five states due to a lack of processing controls.
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 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.
Kroger Specialty Pharmacy is recalling one lot of Pulmozyme inhalation solution because it lacks processing controls, which may affect product quality.
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 Enbrel PFS 50 mg/mL injections due to a lack of processing controls. The affected lots were dispensed between December 2017 and February 2018.
Kroger Specialty Pharmacy is recalling Revlimid 25 mg oral capsules due to a lack of processing controls. The affected lots were dispensed between December 2017 and February 2018.
Kroger Specialty Pharmacy is recalling Cimzia 200 mg/mL PFS Kits due to a lack of processing controls. The affected lots were dispensed in five states.
Kroger Specialty Pharmacy is recalling Cyclophosphamide 50 mg capsules due to a lack of processing controls. The affected lots were dispensed between December 2017 and February 2018.
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 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 Cosentyx 150 mg/mL prefilled syringes due to a lack of processing controls. The recall affects specific lots dispensed in five states.
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.