Ifosfamide Powder, For Solution
FDA Label NDC 21586-211

September 01, 2026

Temporary Importation of Ifosfamide for Injection with non-U.S. Labeling to Address Drug Shortage

Dear Healthcare Professional:

Due to the current critical shortage of Ifosfamide for Injection products in the United States (U.S.) market, SteriMax USA Inc. (SteriMax), is coordinating with the U.S. Food and Drug Administration (FDA) to temporarily import unapproved Ifosfamide for Injection, 1g/vial currently marketed in China. FDA has not approved imported Ifosfamide for Injection from Qilu Pharmaceuticals Co. Ltd in the United States. The imported Ifosfamide for Injection is manufactured at an FDA-inspected facility.

At this time, no other entity except SteriMax USA Inc., NJ or its distributor GlobalRX, NC is authorized by the FDA to import or distribute imported Ifosfamide for Injection in the United States.

Effective immediately, GlobalRX will distribute the following presentations of imported Ifosfamide for Injection to address the critical shortage:

The barcode on the imported product carton label may not register accurately on the U.S. scanning systems. Institutions should manually input the imported product information into their systems and confirm that the barcode, if scanned, provides correct information. Alternative procedures should be followed to assure that the correct drug product is being used and administered to individual patients.
In addition, the packaging of the imported product does not include serialization information. Imported Ifosfamide for Injection does not meet the Drug Supply Chain Security Act (DSCSA) requirements for the Interoperable Exchange of Information for Tracing of Human, Finished Prescription Drugs.

It is important to note the following:

• The imported product should be stored under refrigeration at 2°C to 8°C, protected from light, and sealed. These storage instructions differ from the FDA-approved product. The storage conditions are supported by stability and compatibility studies.
• Reconstitution and administration instructions differ between the imported product label and the FDA-approved IFEX labeling. The FDA-approved IFEX labeling provides specific reconstitution volumes, final concentration, further dilution options, and stability instructions; the imported package insert directs reconstitution with sterile water for injection, further dilution with 500 to 1000 mL of 0.9% Sodium Chloride Injection or 5% Dextrose Injection, and slow intravenous infusion over at least 30 minutes. Refer to the Product Comparison Table for details.
• The Chinese vial label and carton are over labeled with English labels, as shown in the Product Comparison Table below. Healthcare professionals should use the English over labels, English translation, and Product Comparison Table to verify the product name, strength, storage, handling, reconstitution, and administration information before use.
• The imported product contains excipients, glycine and mannitol, whereas FDA-approved IFEX contains no excipients.
• In addition, the imported package insert lists different drug interaction information than the FDA-approved IFEX labeling; healthcare professionals should review the Product Comparison Table and FDA-approved IFEX prescribing information before prescribing, preparing, or administering imported Ifosfamide for Injection.


Ifosfamide for Injection is available only by prescription in the U.S. Please refer to the package insert provided here for the FDA-approved Ifosfamide for Injection drug product for full prescribing information.


Finally, please ensure that your staff and others in your institution who may be involved in the administration of Ifosfamide for Injection receive a copy of this letter and review the information.


If you have any questions about the information contained in this letter, any quality related problems, or questions on the use of imported Ifosfamide for Injection, please contact SteriMax USA Inc. at 1-877-373-4657.


To place an order, please contact GlobalRX at [email protected] or (919) 245-8418.


Healthcare providers should report adverse events associated with the use of imported Ifosfamide for Injection to SteriMax USA Inc. at 1-877-373-4657 and/or by e-mail [email protected].


Adverse events, medication errors, or quality problems experienced with the use of this product may also be reported to the FDAs MedWatch Adverse Event Reporting Program either online, by regular mail, or by fax:

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.


We remain at your disposal to answer any questions you may have about our product; and provide more information if needed.


Sincerely,



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Ritesh Acharya

Chief Scientific Officer

SteriMax Inc.





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