Class II
Ongoing
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
This recall is currently active, issued November 8, 2023. It was issued by Padagis Us Llc.
- Company
- Padagis Us Llc
- Recall Initiated
- September 28, 2023
- Posted
- November 8, 2023
- Recall Number
- D-0081-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 10,512 cartons
- Firm Location
- Minneapolis, MN, United States
- Official Source
- View on FDA website ↗
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
Nationwide within the United States
Lot / Code Info
Lot#: 164185, Exp. Date 4/2024
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