Sunny Pharmtech has issued a nationwide recall for three lots of its Cyclophosphamide for Injection, USP, 1g/vial and 2g/vial, due to the discovery of steel particulate matter within the vials. This recall carries a significant risk of serious adverse events, including death, particularly for vulnerable cancer patients receiving intravenous infusions.
The affected product was distributed to wholesalers, distributors, hospitals, and pharmacies between May 2024 and October 2024. While the presence of particulate matter can lead to complications such as phlebitis, granuloma, occlusion, or life-threatening thromboembolic events, especially in immunosuppressed individuals, no adverse events or injuries related to this issue have been reported to date.
Cyclophosphamide for Injection, USP, is prescribed for various malignant diseases, including lymphomas, leukemias, and breast carcinoma, as well as for minimal change nephrotic syndrome in pediatric patients. Consumers are advised to contact their physician if they experience any problems and should not alter prescribed treatment without medical consultation. Healthcare providers are instructed to immediately cease use, quarantine, and return all affected inventory.