American Regent, Inc.: Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 05…
| Source | FDA · Drugs (US) |
|---|---|
| Date | 2026-08-26 |
| 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 / hazard | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde |
| Classification | Class II |
| Official notice | — |
| Record ID | fda-drug:D-0795-2026 |