14,450 recalls · Class II, newest first
Reason Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
Reason Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Reason Failed Stability Specifications
Reason Failed Stability Specifications
Reason Lack of Assurance of Sterility: Firm did not perform process validation.
Reason Lack of Assurance of Sterility: Firm did not perform process validation.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Failed Stability Specification: Water determination was found not complying with specification.
Reason Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Reason Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Reason Failed Dissolution Specifications
Reason Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Reason Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Reason Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.