Hikma Pharmaceuticals recalls Bleomycin injection vials due to mislabeling. This may affect patients using prescription cancer treatment. Contact Hikma for details.
Labeling: Not elsewhere classified: Mislabeling
Hik: Hikma Pharmaceuticals is recalling Bleomycin injection vials because they were mislabeled. This could lead to incorrect dosing for patients receiving cancer treatment.
The vials were mislabeled, which could lead to incorrect dosing for patients. This is a labeling issue that does not involve physical hazards like breakage or fire.
Patients prescribed Bleomycin for cancer treatment who received the recalled vials. Those with the specific NDC number 0143-9240-01 are most at risk.
Check for vials labeled 'Bleomycin for Injection, USP, 15 units per single dose vial, Rx only' with NDC number 0143-9240-01. The vials were manufactured by Thymoorgan Pharmazie in Germany.
Look for the NDC number 0143-9240-01 on the vial label.
No, this is a mislabeling issue that does not involve physical hazards like breakage or fire. It could lead to incorrect dosing but is not immediately dangerous.
Check for vials labeled 'Bleomycin for Injection, USP, 15 units per single dose vial, Rx only' with NDC number 0143-9240-01.
The recall does not specify a remedy, so contact Hikma Pharmaceuticals for guidance.
We’ve drafted a message you can send Hikma to request your refund or repair — edit it as you like.
Subject: Recall D-0771-2021 — Hikma Hikma Hello, I own a Hikma that is covered by recall D-0771-2021 from Hikma. 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.