D-0081-2024 Class II Ongoing
FDA drug recall D-0081-2024 was initiated by Padagis US LLC on September 28, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 10,512 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- November 8, 2023
- Initiation Date
- September 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,512 cartons
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
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.
Distribution Pattern
Nationwide within the United States
Code Information
Lot#: 164185, Exp. Date 4/2024