Padagis US LLC: Drug Recall

Recall #D-0139-2024 · 11/01/2023

Class II: Risk

Recall Details

Recall Number: D-0139-2024
Classification: Class II
Product Type: Drug
Recalling Firm: Padagis US LLC
Status: Ongoing
Date Initiated: 11/01/2023
Location: Minneapolis, MN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7,032 bottles

Reason for Recall

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

Product Description

Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun-248 197 Uttarakhand, India Distributed By: Padagis, Allegan, MI 49010. NDC: 0574-0118-30

Distribution Pattern

Nationwide in the USA

Other Recalls by Padagis US LLC

Class II: Risk 02/06/2025

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

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 09/28/2023

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

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

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

View all recalls by Padagis US LLC →

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.