FDA-Drug2026-08-26Class IIPROCESSING DEFECT
American Regent Tralement trace elements injection recalled for particulate contamination
What this means
American Regent's Tralement (trace elements injection) contains particulate matter including hair, glass, and/or paraformaldehyde. The contamination affects specific lots with expiration dates in April and September 2027. This is a prescription medication used in clinical settings.
- If you have received this medication, do not use it.
- Contact your healthcare provider or pharmacy immediately.
- Check lot numbers 25149 (exp. 04/30/2027) and 25371 (exp. 09/30/2027).
- Report any use of this product to the FDA MedWatch program or your healthcare provider.
The agency's original wording
Hazard
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the U.S
Affected count
323,000 vials
Manufactured in
5 Ramsay Rd, Shirley, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0801-2026More American Regent recalls
- FDA-Drug2026-09-16American Regent epinephrine injection recalled for particulate matter and sterility concerns
- FDA-PR2026-09-03American Regent epinephrine injection recalled for particulate matter and sterility concerns
- FDA-Drug2026-08-26American Regent Cyanocobalamin injection recalled for particulate contamination
- FDA-Drug2026-08-26American Regent aminocaproic acid injection recalled for particulate contamination
- FDA-Drug2026-08-26American Regent Selenious Acid Injection recalled for particulate contamination
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