Drug recall D-0800-2026
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
Lots and codes
Lot #: 25202, Exp. Date: 11/30/2026.
Recall details
- Recalling firm
- American Regent, Inc., Shirley, NY
- Quantity
- 86,100 vials
- Distribution
- Nationwide within the U.S
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 24, 2026
Related products
- Papaverine Hydrochloride – drug information
- NDC 0517-4002 Papaverine Hydrochloride · Papaverine Hydrochloride 30 mg/mL · American Regent, Inc.