Padagis US LLC: Drug Recall

Recall #D-0081-2024 · 09/28/2023

Class II: Risk

Recall Details

Recall Number: D-0081-2024
Classification: Class II
Product Type: Drug
Recalling Firm: Padagis US LLC
Status: Ongoing
Date Initiated: 09/28/2023
Location: Minneapolis, MN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10,512 cartons

Reason for Recall

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

Product Description

Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per carton, Rx Only, Manufactured By Padagis, Yeruham, Israel; Distributed By: Padagis, Allegan, MI 49010. NDC: 45802-396-01

Distribution Pattern

Nationwide within the United States

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 11/01/2023

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