Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL
Product details
- Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL
Company announcement
American Regent, Inc. is conducting a nationwide voluntary recall of a single lot of Papaverine Hydrochloride Injection, USP, 60 mg/2 mL single dose vial.
The product is being recalled due to the presence of particulate matter identified as glass and/or paraformaldehyde.
The affected product was distributed nationwide in the United States beginning September 30, 2025.
To date, American Regent, Inc. has not received any reports of adverse events related to this recall.
Risk:
The administration of an injectable product containing particulate matter may result in local irritation or swelling. The particulate matter could travel through and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. Patients with underlying cardiovascular or pulmonary compromise may be at increased risk.
Impacted states: Nationwide
Products:
- Papaverine Hydrochloride Injection, USP 60 mg/2 mL Single dose vial
Contact
For more information, call (800) 645-1706.