#United States #Product Recall #Shirley #American Regent #Papaverine Hydrochloride

American Regent, Inc. Undertakes Nationwide Recall of Papaverine Hydrochloride Injection

American Regent, Inc., a prominent entity in the pharmaceutical industry, has instigated a voluntary nationwide recall of a singular lot of its product, Papaverine Hydrochloride Injection, USP, which is packaged in 2 mL single-dose vials. The reason for this action stems from the detection of visible particulate matter within the vials, specifically identified as glass and/or paraformaldehyde, prompting immediate precautionary measures to safeguard public health.

Overview of the Product

Papaverine Hydrochloride is a prescription medication predominantly employed to alleviate smooth muscle spasms and improve blood circulation. The injection is colorless to pale yellow and is typically utilized in medical settings under stringent physician guidance. The specific lot number being recalled is #25202, with an expiration date set for November 30, 2026. The distribution of this lot commenced on September 30, 2025, to various healthcare facilities and pharmacies across the United States.

Associated Risks

The recall has been issued due to potential risks associated with the administration of this product containing particulate matter. Such impurities could pose serious health risks, including local irritation and swelling, as well as more severe events like blockage of blood vessels, potentially leading to strokes or even fatalities. Notably, patients with existing cardiovascular or pulmonary issues may face heightened risks.

Despite the gravity of the situation, American Regent, Inc. has confirmed that there have been no reported adverse events linked to the recalled lot so far. Nonetheless, the company is taking this initiative to uphold the safety and well-being of the patients who rely on its products.

Actions Taken by American Regent, Inc.

To mitigate any risks, American Regent, Inc. is proactively notifying its distributors, healthcare facilities, and consumers about the recall through letters. The company is facilitating the return and replacement of all affected products. Distribution points that possess the recalled products are advised to halt usage immediately and either return them to the point of purchase or discard them.

Healthcare professionals and consumers who may have inquiries can reach out to American Regent, Inc. via their customer service line at 800-645-1706, available Monday to Thursday from 8:00 AM to 6:00 PM EST, and on Friday from 8:00 AM to 4:00 PM EST.

Patients who have been prescribed this specific lot of Papaverine Hydrochloride Injection should cease its use immediately and consult their healthcare provider for further guidance and alternative treatment options. Furthermore, any adverse reactions or product quality issues experienced with this medication can be reported to the FDA's MedWatch program, which is dedicated to monitoring the safety of medical products and ensuring the welfare of the public.

Conclusion

American Regent, Inc. remains committed to the safety of its consumers and is taking responsible steps in recalling this lot of Papaverine Hydrochloride Injection. By prioritizing public health and safety, the company aims to reassure patients and healthcare providers that it is actively engaged in addressing any potential risks associated with its products. As the situation develops, they continue to emphasize transparency and open communication with all stakeholders involved in healthcare services.