Class II ยท Moderate risk
Gynazole-1
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
National Drug Code
Is NDC 45802-0396-01 recalled?
gynazole 1 · 1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-01) / 5.8 g in 1 TUBE, WITH APPLICATOR
Yes — this exact package was recalled
1 FDA recall names the code 45802-0396-01 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
1 of these recalls is still ongoing.
- Active ingredient
- butoconazole nitrate
- Strength
- BUTOCONAZOLE NITRATE 100 mg/5g
- Form
- Cream · Vaginal
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Type
- Human Prescription Drug
- Product code
- 45802-0396
Recalls naming this package
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 45802-0425 See recall 2
- 45802-0571 See recall 2
- 45802-0868 Polyethylene Glycol 3350 2
- 45802-0014 Hydrocortisone 1
- 45802-0054 Triamcinolone Acetonide 1
- 45802-0059 Nystatin 1
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