United StatesNystatin 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, lot 205060, exp 09/30/2027 is being recalled nationwide in the United States by Padagis US LLC. The product was recalled because long-term stability testing showed low out-of-specification assay results indicating the drug may be subpotent.
What's being recalled
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
Recalling firm: Padagis US LLC, Minneapolis, MN, United States.
How to identify it
Lot #: 205060, Exp 09/30/2027
The hazard
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
USA Nationwide
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)