Cyclophosphamide Injection Recalled for Package Insert Concentration Labeling Error
X-Gen Pharmaceuticals recalls Cyclophosphamide for Injection due to a labeling error in the Package Insert. Section 2.3 incorrectly lists the concentration as '20 mg per vial' instead of the correct '20 mg per mL'.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall involving a labeling error without reported illnesses or injuries. Per the rubric, Class III recalls typically score 1 or 2, and theoretical hazards without reported harm are capped at score 3. The concentration mislabeling on a chemotherapy package insert justifies a Moderate score.
Plain-English summary
X-Gen Pharmaceuticals Inc. is recalling Cyclophosphamide for Injection, USP, 1g/vial with Lot #CIC2-23001 A and expiration date 11/30/2026. A total of 1,332 vials have been distributed nationwide in the United States.
The product is a single dose vial containing cyclophosphamide as a lyophilized (freeze-dried) powder that must be reconstituted before intravenous administration. Cyclophosphamide is a cytotoxic chemotherapy agent used in cancer treatment.
The recall was initiated due to a labeling error in the Package Insert. Section 2.3 'Preparation, Handling, and Administration' incorrectly lists the concentration of the reconstituted product as '20 mg per vial' when it should read '20 mg per mL'.
The recalled product
- Product
- Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted before intravenous infusion, Rx Only, Manufactured for: XGen Pharmaceuticals DJ
- Manufacturer
- X-Gen Pharmaceuticals Inc.
- Category
- Drug — Injectable Chemotherapy
- Hazard
- Affected units
- 1,332
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: CIC2-23001 A
- Exp. 11/30/2026
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by X-Gen Pharmaceuticals Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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