Kitabis Pak 300 mg/5 mL Soln PARI #56 NDC 24492-0850-56 56 days supply
Kroger Specialty Pharmacy
Lack of Processing Controls.
Prescription and over-the-counter medications
Kroger Specialty Pharmacy
Lack of Processing Controls.
Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result that was obtained for related substance (Phentolamide), a known degradation product impurity at the 15 month stability test point.
Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.
Kroger Specialty Pharmacy
Lack of Processing Controls.
Kroger Specialty Pharmacy
Lack of Processing Controls.
Kroger Specialty Pharmacy
Lack of Processing Controls.
Kroger Specialty Pharmacy
Lack of Processing Controls.
Kroger Specialty Pharmacy
Lack of Processing Controls.
Kroger Specialty Pharmacy
Lack of Processing Controls.
Kroger Specialty Pharmacy
Lack of Processing Controls.
Kroger Specialty Pharmacy
Lack of Processing Controls.
Kroger Specialty Pharmacy
Lack of Processing Controls.
Kroger Specialty Pharmacy
Lack of Processing Controls.
Kroger Specialty Pharmacy
Lack of Processing Controls.
Kroger Specialty Pharmacy
Lack of Processing Controls.
Kroger Specialty Pharmacy
Lack of Processing Controls.
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.
Kroger Specialty Pharmacy
Lack of Processing Controls.
Kroger Specialty Pharmacy
Lack of Processing Controls.
Kroger Specialty Pharmacy
Lack of Processing Controls.