Recalls / Class II
Class IID-0081-2024
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
- Brand name
- Gynazole 1
- Generic name
- Butoconazole Nitrate
- Active ingredient
- Butoconazole Nitrate
- Route
- Vaginal
- NDC
- 45802-396
- FDA application
- ANDA200923
- Affected lot / code info
- Lot#: 164185, Exp. Date 4/2024
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.
Recalling firm
- Firm
- Padagis US LLC
- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3940 Quebec Ave N, N/A, Minneapolis, Minnesota 55427-1244
Distribution
- Quantity
- 10,512 cartons
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2023-09-28
- FDA classified
- 2023-10-31
- Posted by FDA
- 2023-11-08
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0081-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.