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Subpotent Drug
Out of specification for assay
Cross Contamination with Other Products
Sub-potent Drug; powder discoloration associated with decreased potency
FDA Analysis found product labeled as tejocote is actually yellow oleander, which is toxic to humans.
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
CGMP Deviations
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Presence of Particulate Matter.
Lack of Assurance of Sterility: Firm did not perform process validation.