FDARecalled Nov 8, 2023 · #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; D...
Hazard
Class II — temporary health risk
Be the first to hear about future recalls.
Add the things you own to a watchlist. We’ll alert you the moment one matches.
Get started, freeDescription
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process. Classification: Class II Distribution: Nationwide within the United States
Product details
- Product
- 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
- Type
- Drugs
- Manufacturer
- Padagis US LLC
- Model numbers
- 164185
- UPCs
- —