American Regent, Inc.: Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b)…
| Source | FDA · Drugs (US) |
|---|---|
| Date | 2026-08-26 |
| 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 / hazard | Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde |
| Classification | Class I |
| Official notice | — |
| Record ID | fda-drug:D-0800-2026 |