Padagis US LLC recalls Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per…
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Read the official notice →- Date
- 2023-11-08
- Country
- United States
- Brand
- Padagis
- Product
- Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per…
- Classification
- Class II
- Units
- Nationwide within the United States
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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