Recall RadarTralement (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,…
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Read the official FDA notice →What to do
Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.
Details
- Recalling company
- American Regent, Inc. — Shirley, NY
- Severity
- Class II — moderate
- Reported
- August 26, 2026
- Quantity
- 323,000 vials
- Recall number
- D-0801-2026
- Status
- Ongoing
- Source
- FDA
Where it went
Nationwide within the U.S
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