Presence of particulate matter - Glass like particles.
Imprimis NJOF
Presence of particulate matter - Glass like particles.
Class I - Dangerous
Presence of particulate matter - Glass like particles.
Subpotent Drug
Sub-Potent Drug: Subpotent assay results during stability testing.
Class I - Dangerous
Sub-Potent Drug: Subpotent assay results during stability testing.
Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
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
Subpotent Drug
Out of specification for assay
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Subpotent: Failing Test Results for Epinephrine
Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Class I - Dangerous
Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.