Overview of recall records associated with Padagis US LLC, including dates, categories and classifications where available.
Classification mix: Class II: 5, Class III: 2.
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
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.
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Defective Delivery System
This page summarizes recall records in which the official source identifies Padagis US LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
