Fagron recalls 6482 units/mg NYSTATIN 150 MU bulk powder due to label error on declared strength. This affects prescription compounding. No action needed as it's a labeling issue, not a safety hazard.
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Fagron is recalling a specific bulk powder for prescription compounding because the label shows an incorrect strength. This is a labeling error, not a safety risk, so no action is required.
The label incorrectly states the strength of the NYSTATIN powder. This could lead to incorrect dosing if compounded without verifying the actual strength. However, it does not pose a direct safety risk to users.
Prescription compounding pharmacies using this specific bulk powder for medication preparation. The risk is minimal since it's a labeling error, not a safety hazard.
Check for the NDC code 51552-0041-1 on the container. The product was sold with lot number 221031-U42104 and expires April 30, 2025. This is for prescription compounding only.
Check the NDC code 51552-0041-1 and lot number 221031-U42104 on the container.
No, this is a labeling error, not a safety hazard. No action is needed.
No action is required. This is a labeling issue, not a safety risk.
Look for the NDC code 51552-0041-1 and lot number 221031-U42104 on the container.
We’ve drafted a message you can send Fagron to request your refund or repair — edit it as you like.
Subject: Recall D-0157-2024 — Fagron Fagron Hello, I own a Fagron that is covered by recall D-0157-2024 from Fagron. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
