COMPANY ANNOUNCEMENT
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company’s announcement as a public service. FDA does not endorse either the product or the company.
Summary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
-
Recall Reason Description
Products were found to contain particulate matter
- Company Name:
- American Regent, Inc.
- Brand Name:
-
Brand Name(s)
American Regent, Inc.
- Product Description:
-
Product Description
Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL
Company Announcement
Papaverine Hydrochloride Injection, USP Lot # 25202 was distributed nationwide in the United States beginning September 30, 2025. NDC, lot, expiration date and distribution dates can be found on the table below.
| Contact Center | Contact Information | Area of Support |
|---|---|---|
| American Regent, Inc. Customer Service | Phone: 800-645-1706 (8:00AM-6:00PM EST, Monday – Thursday, 8:00AM-4:00PM EST, Friday) | For detailed return/replacement/credit information |
| American Regent, Inc. Pharmacovigilance | Phone: 800-734-9236 Email: pv@americanregent.com | To report adverse events |
| American Regent, Inc. Product Quality Complaints | Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday – Friday) Email: pqc@americanregent.com | For product quality complaints |
| American Regent, Inc. Medical Information | Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday – Friday) Email: ma@americanregent.com | For medical questions |
Company Contact Information
- Consumers:
- (800) 645-1706
Product Photos
