Testosterone Cypionate/Enanthate/Propionate 80/80/40mg, a) 5 mL-vial, b) 10 ml-vial, Room temperature, Tailor Made Compounding
TMC Acquisition LLC
Lack of Assurance of Sterility
Prescription and over-the-counter medications
TMC Acquisition LLC
Lack of Assurance of Sterility
TMC Acquisition LLC
Lack of Assurance of Sterility
TMC Acquisition LLC
Lack of Assurance of Sterility
TMC Acquisition LLC
Lack of Assurance of Sterility
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and dexamethasone.
TMC Acquisition LLC
Lack of Assurance of Sterility
TMC Acquisition LLC
Lack of Assurance of Sterility
TMC Acquisition LLC
Lack of Assurance of Sterility
TMC Acquisition LLC
Lack of Assurance of Sterility
TMC Acquisition LLC
Lack of Assurance of Sterility
TMC Acquisition LLC
Lack of Assurance of Sterility
Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
TMC Acquisition LLC
Lack of Assurance of Sterility
TMC Acquisition LLC
Lack of Assurance of Sterility
TMC Acquisition LLC
Lack of Assurance of Sterility
Labeling: Label Mix-Up-The primary label on the front of the bottles have Hydrogen Peroxide affixed to the front and back of the containers. However, the product inside the bottle is 70% Isopropyl Alcohol.
TMC Acquisition LLC
Lack of Assurance of Sterility
TMC Acquisition LLC
Lack of Assurance of Sterility
TMC Acquisition LLC
Lack of Assurance of Sterility
CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.