Recall D-0800-2026

US Class I Ongoing · initiated 2026-07-24

Recalling firm

American Regent, Inc., NY

Product

Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Vials (NDC 0517-4002-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.

Reason for recall

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

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