FDAFDA · Food and drugs·Recall number D-0081-2024
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
Published November 8, 2023 · Recall initiated: September 28, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- GYNAZOLE 1
- Manufacturer
- Padagis US LLC
- Distributor
- Nationwide within the United States
- Lot
- Lot#: 164185, Exp. Date 4/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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