Padagis US LLC 2023-11-08 Health serious FDA
Health · FDA · Recall #FDA-D-0081-2024
Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled… Recall
Issued November 8, 2023 · Padagis US LLC
In November 2023, Padagis US LLC recalled the Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
What you should do
- 1 Stop using Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Padagis US LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Padagis US LLC
- Category
- Health
- Recall date
- November 8, 2023
- Units affected
- Not reported
- Sold at
- Nationwide within the United States
- Recall number
- FDA-D-0081-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Padagis US LLC has 7 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.