Fagron recalls 500 MU NYSTATIN bulk powder due to incorrect label strength. This affects prescription compounding. No action needed as it's a labeling error, 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 the wrong strength. This is a labeling error, not a safety issue, so no action is required.
The label incorrectly states the strength of the NYSTATIN powder. This could lead to incorrect dosing if compounded by a pharmacy, but it's not a safety hazard.
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 51552-0041-3, lot numbers 230308-U46225 or 221031-U42110, and expiration dates of 04/30/2025. This product is for prescription compounding only.
Verify the label shows the correct strength of 500 MU for NYSTATIN powder.
No, this is a labeling error, not a safety hazard. No action is needed.
No action is required as it's a labeling error, not a safety issue.
Look for NDC code 51552-0041-3, lot numbers 230308-U46225 or 221031-U42110, and expiration date 04/30/2025.
We’ve drafted a message you can send Fagron to request your refund or repair — edit it as you like.
Subject: Recall D-0155-2024 — Fagron Fagron Hello, I own a Fagron that is covered by recall D-0155-2024 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.
