Reported Nov 8, 2023 · Ongoing
Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1…
Padagis US LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Padagis US LLC · 3940 Quebec Ave N · Minneapolis, MN · 55427-1244
Is this the product you have?
- 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 ByPadagis, Allegan, MI 49010
- NDC45802-396-01
- Lot codes and dates
Lot#: 164185Exp. Date 4/2024
- Amount recalled
- 10,512 cartons
Where it was sold
- Nationwide
Why it was recalled
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
This product could cause temporary or reversible health problems — stop using it.
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