Padagis US LLC

12 FDA enforcement records linked to this company.

• recall — Class II2025-03-05

  Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.

• recall — Class III2024-11-27

  Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.

• 4832024-09-06

  Cleaning SOP/inspection

• recall — Class II2023-12-13

  Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules

• recall — Class II2023-11-08

  Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.

• recall — Class III2023-03-22

  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.

• recall — Class II2022-09-07

  CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.

• 4832022-02-18

  Authority lacking to review records, investigate errors

• 4832022-02-18

  Procedures not in writing, fully followed

• 4832022-02-18

  Procedures To Be in Writing

• recall — Class II2022-01-19

  Defective Delivery System

• warning_letter2010-03-01

  FDA Warning Letter (drug product)