FDA MedWatch - Cyclophosphamide for Injection, USP to the User Level by Sunny Pharmtech

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TOPIC: Cyclophosphamide for Injection, USP to the User Level by Sunny Pharmtech: Recall - Due to the Presence of Particulate Matter

AUDIENCE: Patient, Health Care Professional, Risk Manager, Pharmacy, Oncology

ISSUE: Sunny Pharmtech is recalling three lots of Cyclophosphamide for Injection, USP, 1g/vial and 2g/vial, due to the presence of particulate matter identified as steel.

Risk Statement: There is a reasonable probability for serious adverse events, including death, should a patient receive intravenous infusion of product found to contain particulate matter. For the population most at risk, cancer patients who are likely to have numerous pre-existing comorbidities and may be immunosuppressed due to concomitant or prior treatment and nutritional issues related to their cancer, complications can include phlebitis, granuloma, and occlusion or life-threatening thromboembolic events.

The affected product was distributed to wholesalers, distributors, hospitals and pharmacies from May 2024 to October 2024. 

To date, no adverse events or injuries associated with this particulate matter issue have been reported.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: Cyclophosphamide for Injection, USP is indicated for treatment of malignant diseases (malignant lymphomas; Hodgkin’s disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma) and minimal change nephrotic syndrome in pediatric patients (biopsy-proven minimal change nephrotic syndrome patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy).

RECOMMENDATIONS:

• Consumers should contact their physician or healthcare provider if they have experienced any problem that may be related to taking or using this drug product and should not stop or change prescribed treatment without consulting a healthcare professional.

• Pharmacies, hospitals, and other healthcare providers that have the recalled product should immediately stop use and dispensing, and quarantine all affected product inventory, and follow the instructions in the recall notification for arranging return of the affected lots to Cardinal Health.

• Consumers with questions regarding this recall may contact Sunny Pharmtech, Inc. at +886-3-480-9168, Ext. 7205 or ra@sunnypharmtech.com.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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