Tralement (trace elements injection 4*, USP) recall
American Regent, Inc. recalled Tralement (trace elements injection 4*, USP) on August 26, 2026 because of presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde. It was sold nationwide.
Why it was recalled
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
What's recalled
Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Quantity: 323,000 vials
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- American Regent, Inc., Shirley, NY
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
Nationwide within the U.S - Status
- Ongoing
- Recall number
- D-0801-2026
- Source
- U.S. Food and Drug Administration
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