Sun Pharmaceutical recalls 50mg Amphotericin B Liposome vials (NDC 62756-233-01) due to assay out of specification. This may affect drug effectiveness. Contact the manufacturer for details.
Out of specification for assay
Sun Pharmaceutical is recalling 50mg Amphotericin B Liposome for Injection vials because they were made with an assay that doesn't meet specifications. This could mean the medication isn't working properly for patients who need it.
The medication's assay (a measure of active ingredient) is outside acceptable limits. This could lead to the drug not being effective when needed for serious infections.
Patients prescribed this medication by a doctor are affected. Those with specific medical conditions requiring this drug are at higher risk.
Check for vials labeled 'Amphotericin B Liposome for Injection, 50mg' with NDC 62756-233-01 and lot numbers BAE0055A, BAE0056A, or BAE0068A. These were distributed by Sun Pharmaceutical Industries, Inc. in the US.
Look for the NDC code 62756-233-01 and lot numbers BAE0055A, BAE0056A, or BAE0068A on the vial label.
The recall is due to the assay being out of specification, which may affect effectiveness. Do not use the medication until you confirm it's not recalled.
Check for vials with NDC 62756-233-01 and lot numbers BAE0055A, BAE0056A, or BAE0068A.
Contact Sun Pharmaceutical Industries, Inc. for instructions on what to do with the medication.
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0493-2024 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0493-2024 from Sun Pharmaceutical. 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.
