Categories
Resources
Your Recalls
Loading...
Get email alerts when new recalls match your interests.
CGMP Deviations: recalling drug products following an FDA inspection.
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Subpotent Drug