The U.S. Food and Drug Administration (FDA) has announced a nationwide recall of three lots of Cyclophosphamide for Injection, USP, after discovering steel particulate matter in the injectable cancer drug. The recall was initiated by Sunny Pharmtech Inc., the manufacturer of the affected products, which were distributed to wholesalers, distributors, hospitals, and pharmacies between May and October 2024.
Affected Products
The recalled products may contain steel particles, which could enter a patient’s bloodstream during intravenous infusion, potentially leading to serious adverse health consequences, including death. Cyclophosphamide is a chemotherapy drug used to treat various types of cancer, including Hodgkin’s lymphoma, leukemia, and breast cancer.
Patients who receive contaminated intravenous doses face a reasonable probability of serious adverse health consequences. However, no injuries or adverse events related to the recall have been reported to date. The FDA advises patients not to discontinue prescribed treatment on their own and to contact their physician or healthcare provider if they have any concerns.
Original reporting: The Dallas Express — read the source article.
