American Regent recalls one lot of Papaverine Hydrochloride injection over glass particles

American Regent announced a voluntary nationwide recall of a single lot of its Papaverine Hydrochloride Injection, USP 60 mg/2 mL, after detecting visible particulate matter.

The particles were identified as glass and/or paraformaldehyde. The company warned that injecting a product containing such material could cause local irritation, swelling, or block blood vessels, potentially leading to serious complications such as stroke or death, especially in patients with cardiovascular or pulmonary issues.

No adverse events have been reported to date. The recall targets consumer-level vials and the company is working with the FDA to remove the affected lot from the market.