Class II · Moderate risk
Nystatin Cream USP
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Gynazole-1 (Butoconazole Nitrate)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
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
Affected NDC
45802-0396-01
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| gynazole 1 butoconazole nitrate NDC 45802-0396 |
100 mg/5g | Cream Vaginal |
Padagis Israel Pharmaceuticals Ltd | Rx |
- Recalling firm
- Padagis US LLC
- Origin
- MN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0081-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other recalls by Padagis US LLC
All 2023 recalls
Class II · Moderate risk
Estradiol Gel
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Class III · Low risk
Triamcinolone Acetonide Cream USP
Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
Class II · Moderate risk
Trospium Chloride Extended-Release Capsules
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
Other cgmp deviation recalls from 2023
All cgmp deviation recalls
Class II · Moderate risk
Sertraline Tablets
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Class II · Moderate risk
Oxygen
cGMP Deviations
Class III · Low risk
V-FORCE Homeopathic
Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).
Class II · Moderate risk
Strong Iodine Solution U.S.P.
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
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