AuroMedics Pharma LLC recalls Tranexamic Acid 1000mg/10mL vials due to metal particles found in some batches. This could cause injury during injection. Return or discard affected vials immediately.
Presence of Particulate Matter: Piece of metal found in a vial
AuroMedics Pharma LLC is recalling Tranexamic Acid Injection vials that contain metal particles. Using these vials could cause injury during medical procedures. Affected vials have specific lot numbers and expiration dates.
Metal particles in the vial could cause injury when injected into the body. This is a serious hazard during medical procedures as the particles may damage tissues or cause complications.
People prescribed Tranexamic Acid by a doctor who received this specific vial from AuroMedics Pharma LLC. Patients using the product for medical procedures are most at risk.
Check for the lot number CTA210006 on the vial label. The vial expires February 2024 and was made in India. This product is only available by prescription.
Look for the lot number CTA210006 and expiration date of 02/2024 on the vial.
If the vial has the lot number CTA210006, discard it immediately or contact your doctor for instructions.
No, this specific batch contains metal particles that could cause injury during injection. Do not use vials with lot number CTA210006.
Discard the vial immediately or contact your doctor for instructions on how to handle it.
Check for the lot number CTA210006 and expiration date of February 2024 on the vial label.
We’ve drafted a message you can send AuroMedics to request your refund or repair — edit it as you like.
Subject: Recall D-1551-2022 — AuroMedics AuroMedics Hello, I own a AuroMedics that is covered by recall D-1551-2022 from AuroMedics. 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.
