Class II recall: American Regent, Inc.: Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose via

American Regent, Inc. is recalling Tralement (trace elements injection 4*, USP), packaged in 1mL single dose vials (NDC 0517-9305-01) and 5x1mL single dose vials (NDC 0517-9305-25), according to a Class II recall notice. The recall notice states the product was found to be contaminated with particulate matter identified as hair, glass, and/or paraformaldehyde.

Most relevant for: Patients receiving parenteral trace element supplementation who may have been administered contaminated Tralement injections from the affected lot numbers.

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