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Subpotent drug.
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
CGMP Deviations
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
Failed Dissolution Specifications
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.
Labeling: Label mix-up