Class I - Dangerous
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Padagis US
Class I - Dangerous
Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.
Class I - Dangerous
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Defective Delivery System