Custopharm recalls 50mg FLUDARABINE PHOS: manufacturing had microbial issues. Stop using if you have this injection. Details: NDC 24201-237-01, Lot 31327913C, Exp 10/2022.
Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
Custopharm is recalling FLUDARABINE PHOSPHATE injections due to potential contamination from microbial growth during manufacturing. This could lead to serious infections if used improperly.
The manufacturing process had microbial recoveries in sterile areas, meaning the injection could be contaminated. This poses a risk of serious infection or other health complications if used.
Patients prescribed this chemotherapy drug by a doctor. Those with the specific lot number or expiration date are most at risk.
Check the product label for 'FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial'. Look for NDC 24201-237-01 and Lot# 31327913C with an expiration date of 10/2022.
Immediately discard the injection if you have the recalled product.
No, the product has been recalled due to potential contamination risks. Do not use.
Lot# 31327913C.
Check the product label for NDC 24201-237-01 and Lot# 31327913C with an expiration date of 10/2022.
We’ve drafted a message you can send Custopharm to request your refund or repair — edit it as you like.
Subject: Recall D-0765-2021 — Custopharm Custopharm Hello, I own a Custopharm that is covered by recall D-0765-2021 from Custopharm. 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.
