Sunny Pharmtech is voluntarily recalling three lots of Cyclophosphamide for Injection, USP, 1 g/vial and 2 g/vial, to the user level in the United States because of particulate matter identified as steel.
The company said no adverse events or injuries have been reported so far. Still, Sunny Pharmtech warned there is a reasonable probability of serious adverse events, including death, if a patient receives an intravenous infusion containing particulate matter. The risk is especially concerning for cancer patients, who may already have multiple health conditions, weakened immune systems from prior or current treatment, and nutrition-related complications.
The company said contamination could lead to phlebitis, granuloma, and occlusion, as well as life-threatening thromboembolic events. Cyclophosphamide for Injection is used to treat a broad range of malignant diseases, including lymphomas, Hodgkin’s disease, multiple myeloma, leukemias, neuroblastoma, ovarian adenocarcinoma, retinoblastoma, and breast carcinoma. It is also indicated for pediatric patients with biopsy-proven minimal change nephrotic syndrome who failed to respond adequately to, or cannot tolerate, adrenocorticosteroid therapy.
The affected products are packaged as a 1 g/vial, 50 mL single-dose vial in carton NDC 81298-8112-1, and a 2 g/vial, 100 mL single-dose vial in carton NDC 81298-8114-1. The recalled lots are C23019V1, C24015V1, and V24010V1. The product was distributed to wholesalers, distributors, hospitals, and pharmacies between May 2024 and October 2024, and the lots will remain within expiry through October 2026, April 2027, and March 2027, respectively.
Sunny Pharmtech said customers should identify affected product using the lot and package information provided and follow recall instructions.
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