Padagis US LLC: Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-3
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Padagis US LLC
- Product
- Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35
- Reason / hazard
- Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- USA Nationwide
- Recall initiated
- 2026-06-23
- Code info
- Lot #: 205060, Exp 09/30/2027
- Product quantity
- 180,936 tubes
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Minneapolis
- State
- MN
- Country
- United States
- Event id
- 99283
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