Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL
Lack of Assurance of Sterility
948 recalls · Class II, newest first
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Microbial contamination of Non-Sterile Products
Microbial contamination of Non-Sterile Products
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.
Failed Dissolution Specifications
Lack of assurance of sterility:
Lack of assurance of sterility:
Lack of assurance of sterility:
Lack of assurance of sterility:
Lack of assurance of sterility:
Lack of assurance of sterility:
Lack of assurance of sterility:
Lack of assurance of sterility:
Lack of assurance of sterility:
Lack of assurance of sterility:
Lack of assurance of sterility: