X-Gen Pharmaceuticals recalls Cyclophosphamide injection vials due to incorrect concentration labeling on package inserts, which could lead to dosing errors.
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
X-Gen Pharmaceuticals is recalling Cyclophosphamide injection vials because the package insert incorrectly states the concentration as '20 mg per vial' instead of '20 mg per mL'. This could cause dosing errors if the product is used without proper reconstitution.
The package insert incorrectly states the concentration as '20 mg per vial' instead of '20 mg per mL'. This could lead to incorrect dosing if the product is reconstituted without following the proper concentration guidelines.
Patients prescribed Cyclophosphamide injections by healthcare providers in the U.S. who received vials with the specific lot number CIC1-23001 A (expiring 08/30/2026) are affected. Healthcare providers using this product are most at risk.
Check for vials labeled 'Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized' with lot number CIC1-23001 A (expiring 08/30/2026). This product was manufactured by X-Gen Pharmaceuticals in Big Flats, NY.
Verify the concentration label on the package insert states '20 mg per mL' instead of '20 mg per vial'.
The recall is due to incorrect labeling, not a safety issue with the product itself. Using it correctly should not cause harm.
Look for vials with lot number CIC1-23001 A (expiring 08/30/2026) manufactured by X-Gen Pharmaceuticals in Big Flats, NY.
Check the package insert for the correct concentration label. If it states '20 mg per vial' instead of '20 mg per mL', contact your healthcare provider.
We’ve drafted a message you can send X-Gen Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0433-2024 — X-Gen Pharmaceuticals X-Gen Pharmaceuticals Hello, I own a X-Gen Pharmaceuticals that is covered by recall D-0433-2024 from X-Gen Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
