Drug 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
D-0081-2024
Product summary
- Firm
- Padagis US LLC
- Event
- Event 93189
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10,512 cartons
- Official record key
drug-enforcement:D-0081-2024
Official wording
Reason: Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Code information: Lot#: 164185, Exp. Date 4/2024
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.