X-Gen Pharmaceuticals recalls Cyclophosphamide injection vials due to incorrect labeling that could lead to improper dosing. Discard unused solution if you have the specific lot number.
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 a specific type of cyclophosphamide injection vial because 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 used without proper dilution.
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 used without proper dilution, potentially causing under or overdosing.
Patients prescribed cyclophosphamide injections by a doctor who have the specific vial with lot number CIC2-23001 A. Those using the product without proper dilution may face incorrect dosing.
Check for the vial labeled 'Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial' with lot number CIC2-23001 A. The product is a cytotoxic agent requiring a prescription.
Look for the lot number CIC2-23001 A on the vial.
If you have the specific vial with lot number CIC2-23001 A, discard the unused solution immediately.
The package insert incorrectly states the concentration as '20 mg per vial' instead of '20 mg per mL', which could lead to incorrect dosing if the product is used without proper dilution.
If you have the vial with lot number CIC2-23001 A, discard the unused solution immediately.
This product is safe to use only if the concentration is correctly understood and the product is properly diluted as per the updated instructions.
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-0434-2024 — X-Gen Pharmaceuticals X-Gen Pharmaceuticals Hello, I own a X-Gen Pharmaceuticals that is covered by recall D-0434-2024 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.
