Fagron recalls 6482 units/mg NYSTATIN 5BU 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 6482 units/mg of NYSTATIN 5BU 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, which could lead to incorrect dosing if compounded. However, this is a labeling error, not a safety hazard.
Prescription compounding pharmacies that use this specific bulk powder. Compounding pharmacists are most at risk due to potential mislabeling.
Check for the NDC code 51552-0041-5 on the container. The product was sold with lot number 230308-U46196 and expires April 30, 2025.
Verify the label shows the correct strength (6482 units/mg) for NYSTATIN 5BU bulk powder.
No, this is a labeling error, not a safety hazard. No action is needed.
No action is required. This is a labeling error, not a safety issue.
Look for the NDC code 51552-0041-5 on the container, lot number 230308-U46196, and expiration date April 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-0154-2024 — Fagron Fagron Hello, I own a Fagron that is covered by recall D-0154-2024 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.
