American Regent recalls Tralement (trace elements injection) vials due to contamination with hair, glass, and paraformaldehyde. Stop using if you have these specific vial numbers.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent is recalling Tralement injections that may contain hair, glass, or paraformaldehyde particles. Using these contaminated products could cause serious injury or illness.
The product contains harmful particles like hair, glass, and paraformaldehyde. These can cause serious injury or illness if injected into the body.
People with prescriptions for Tralement injections in the specific vial packages listed. Healthcare providers and patients using these products are at risk.
Check for vials labeled 'Tralement (trace elements injection 4*, USP)' with NDC numbers 0517-9305-01 (single dose) or 0517-9305-25 (five doses).
Immediately discard any vials with NDC numbers 0517-9305-01 or 0517-9305-25 that were manufactured in lots 25149 or 25371.
No, the product contains harmful particles that can cause serious injury or illness. Do not use these vials.
Immediately stop using and discard the vials with the specific NDC numbers and lot numbers listed in the recall notice.
Look for vials labeled 'Tralement (trace elements injection 4*, USP)' with NDC numbers 0517-9305-01 (single dose) or 0517-9305-25 (five doses).
We’ve drafted a message you can send American Regent to request your refund or repair — edit it as you like.
Subject: Recall D-0801-2026 — American Regent American Regent Hello, I own a American Regent that is covered by recall D-0801-2026 from American Regent. 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.
