Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Northern VA Compounders PLLC
Lack of Assurance of Sterility
Prescription and over-the-counter medications
Northern VA Compounders PLLC
Lack of Assurance of Sterility
Northern VA Compounders PLLC
Lack of Assurance of Sterility
Northern VA Compounders PLLC
Lack of Assurance of Sterility
Northern VA Compounders PLLC
Lack of Assurance of Sterility
Northern VA Compounders PLLC
Lack of Assurance of Sterility
Northern VA Compounders PLLC
Lack of Assurance of Sterility
Northern VA Compounders PLLC
Lack of Assurance of Sterility
Northern VA Compounders PLLC
Lack of Assurance of Sterility
Northern VA Compounders PLLC
Lack of Assurance of Sterility
Northern VA Compounders PLLC
Lack of Assurance of Sterility
Northern VA Compounders PLLC
Lack of Assurance of Sterility
Northern VA Compounders PLLC
Lack of Assurance of Sterility
Northern VA Compounders PLLC
Lack of Assurance of Sterility
Lupin Pharmaceuticals
Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
Northern VA Compounders PLLC
Lack of Assurance of Sterility
Lack of assurance of sterility: Bags have the potential to leak.
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Jubilant Cadista Pharmaceuticals
Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.