Recall D-0795-2026

US Class II Ongoing · initiated 2026-07-24

Recalling firm

American Regent, Inc., NY

Product

Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1001-01), and b) 25x1 mL Single-Dose Vial (NDC 0517-1001-25), Rx only, AMERICAN REGENT INC., SHIRLEY, NY 11967.

Reason for recall

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

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