Sagent Pharmaceuticals recalls 16mL Docetaxel vials due to particulate matter from stoppers. This may cause serious injury during injection. Check NDC 25021-254-08 and lot F1030001.
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Sagent Pharmaceuticals is recalling 16mL Docetaxel injection vials because they may contain particulate matter from the stopper. This could cause serious injury if injected improperly. The recall affects prescription-only vials made in India with specific NDC and lot numbers.
Particulate matter from the stopper can enter the drug product. If injected, this may cause blockages or serious reactions in the body. The risk is higher when the vial is used without proper filtration.
Prescription patients using this specific Docetaxel injection vial. Those with the NDC 25021-254-08 and lot F1030001 are most at risk.
Check for NDC 25021-254-08 and lot number F1030001 on the vial label. This is a prescription-only 16mL Docetaxel injection vial made in India.
Look for NDC 25021-254-08 and lot F1030001 on the vial label.
The recall states particulate matter may be present, which could cause serious injury during injection. Do not use this vial without checking the recall.
The recall does not specify a remedy, so contact your doctor or pharmacist for guidance.
Check for NDC 25021-254-08 and lot F1030001 on the vial label. This is a prescription-only 16mL Docetaxel injection vial made in India.
We’ve drafted a message you can send Sagent Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0554-2024 — Sagent Pharmaceuticals Sagent Pharmaceuticals Hello, I own a Sagent Pharmaceuticals that is covered by recall D-0554-2024 from Sagent Pharmaceuticals. 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.
