Nasal & Sinus Decongestant
cGMP deviations
14,806 recalls, newest first
cGMP deviations
cGMP deficiencies
Failed stability specifications
Failed stability specifications
Failed stability specifications
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Failed Impurities/Degradation Specifications
Failed Dissolution Specifications.
cGMP deviations
Lack of Assurance of Sterility
Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
Subpotent drug
CGMP Deviations
Failed Stability Specifications
Labeling: Missing Label: label missing from some Semglee prefilled pens.
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications