Padagis US LLC

7 FDA enforcement actions

7 Total Recalls

0 Class I

5 Class II

2 Class III

Firm Details

Product Types: drug
States: MN

All Recalls

Class II: Risk 02/06/2025 drug

Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Class III: Low Risk 10/11/2024 drug

Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
Class II: Risk 11/01/2023 drug

Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
Class II: Risk 09/28/2023 drug

Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Class III: Low Risk 02/21/2023 drug

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 II: Risk 08/17/2022 drug

CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Class II: Risk 12/27/2021 drug

Defective Delivery System

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.