FDA-Drug2023-11-08Class II
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
Padagis US LLC
Hazard
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Sold states
Nationwide within the United States
Affected count
10,512 cartons
Manufactured in
3940 Quebec Ave N, N/A, Minneapolis, MN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0081-2024Don't want to check this manually?
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