Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Drugs Recalls
Prescription and over-the-counter medications
Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml, Sterile injectable, Vitalab Pharmacy, Inc
Vitalab Pharmacy
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
Sutent 37.5 mg capsules x28 NDC 00069-0830-38 28 days supply
Kroger Specialty Pharmacy
Lack of Processing Controls.
OPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply
Kroger Specialty Pharmacy
Lack of Processing Controls.
Sodium Chloride 3% Inh. 4 mL NEP #30 NDC 00487-9003-60 30 days supply.
Kroger Specialty Pharmacy
Lack of Processing Controls.
Vosevi 400/100/100 mg Tablets #28 NDC 61958-2401-01 28 days supply.
Kroger Specialty Pharmacy
Lack of Processing Controls.
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited Bachupally-500 090 India\ NDC 55111-468-01
Dr. Reddy's Laboratories
Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets.
Stelara 90 mg/MI PFS NDC 57894-0061-03 84 days supply
Kroger Specialty Pharmacy
Lack of Processing Controls.
Pomalyst 3 mg capsule NDC 59572-0503-21 28 days supply
Kroger Specialty Pharmacy
Lack of Processing Controls.
Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply
Kroger Specialty Pharmacy
Lack of Processing Controls.
Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply
Kroger Specialty Pharmacy
Lack of Processing Controls.
Cayston 75 mg Inh. Soln. SDV NDC 61958-0901-01 56 days supply
Kroger Specialty Pharmacy
Lack of Processing Controls.
Revlimid 20 mg oral cap NDC 59572-0420-21 28 days supply
Kroger Specialty Pharmacy
Lack of Processing Controls.
Ibrance 125 mg cap NDC 00069-0189-21 28 days supply
Kroger Specialty Pharmacy
Lack of Processing Controls.
Imatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supply
Kroger Specialty Pharmacy
Lack of Processing Controls.
Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, sterile injectable, Vitalab Pharmacy, Inc
Vitalab Pharmacy
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Sprycel 100 mg tablet NDC 00003-0852-22 30 days supply
Kroger Specialty Pharmacy
Lack of Processing Controls.
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Revlimid 10 mg oral cap NDC 59572-0410-28 28 days supply
Kroger Specialty Pharmacy
Lack of Processing Controls.