Sunny Pharmtech Inc. has initiated a nationwide voluntary recall of three specific lots of Cyclophosphamide for Injection, USP. The decision follows the discovery of metal particles within the medication. This intravenous drug is used to treat cancer and other serious conditions, making the presence of steel contaminants a significant safety concern for patients with already compromised immune systems.
The recall involves three specific lots of the drug, which were distributed to wholesalers, hospitals, and pharmacies from May through October 2024. The affected lots include lot C23019V1 (1g), lot C24015V1 (1g), and lot V24010V1 (2g). Health care providers are instructed to stop using these products immediately and quarantine them for return.
Patients who are currently prescribed Cyclophosphamide should not cease their treatment without speaking to their doctor. While there are currently no reports of injuries or adverse health events connected to these metal particles, the company and the FDA note that potential risks include blocked blood vessels, inflammation of veins, and blood clots. Patients should monitor for symptoms and consult their medical team if they have concerns regarding their treatment history.
Sunny Pharmtech is working with Long Grove Pharmaceuticals and Cardinal Health to remove the impacted vials from the supply chain. Any adverse reactions or quality issues related to this medication should be reported to the FDA MedWatch program to assist with ongoing safety oversight.