Class I - Dangerous
Subpotent: Out of specification for assay at the 12-month time point.
Subpotent: Out of specification for assay at the 12-month time point.
Resuspension problems: Out of specification for appearance and resuspendability.
Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.