Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. 30 mL vial for Intra-Catheter Use Only, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676603
KRS Global Biotechnology
Lack of Assurance of Sterility
Prescription and over-the-counter medications
KRS Global Biotechnology
Lack of Assurance of Sterility
Lack of Assurance of Sterility
KRS Global Biotechnology
Lack of Assurance of Sterility
Colonia Care Pharmacy
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
KRS Global Biotechnology
Lack of Assurance of Sterility
KRS Global Biotechnology
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Colonia Care Pharmacy
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
KRS Global Biotechnology
Lack of Assurance of Sterility
Colonia Care Pharmacy
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Lack of Assurance of Sterility
Colonia Care Pharmacy
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
KRS Global Biotechnology
Lack of Assurance of Sterility
Colonia Care Pharmacy
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Lack of Assurance of Sterility
KRS Global Biotechnology
Lack of Assurance of Sterility
Lack of Assurance of Sterility
KRS Global Biotechnology
Lack of Assurance of Sterility
KRS Global Biotechnology
Lack of Assurance of Sterility