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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot#: 164185, Exp. Date 4/2024
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0081-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 28, 2023
- FDA report date
- Nov 8, 2023
- Quantity
- 10,512 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Padagis US LLC
Original FDA data
Every field from FDA enforcement report D-0081-2024, exactly as published.
Show all FDA fields
- City
- Minneapolis
- State
- MN
- Status
- Ongoing
- Country
- United States
- Event ID
- 93189
- Address
- 3940 Quebec Ave N
- Code information
- Lot#: 164185, Exp. Date 4/2024
- Postal code
- 55427-1244
- Report date
- Nov 8, 2023
- Product type
- Drugs
- Recall number
- D-0081-2024
- Classification
- Class II
- Recalling firm
- Padagis US LLC
- Product quantity
- 10,512 cartons
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Sep 28, 2023
- Initial firm notification
- Letter
- Center classification date
- Oct 31, 2023