Cyclophosphamide for Injection recall: Labeling Error
Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For…
Why was Cyclophosphamide for Injection recalled?
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'.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: CIC2-23001 A, Exp. 11/30/2026
- Product
- Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For…
- Recalling firm
- X-Gen Pharmaceuticals Inc.
- Quantity
- 1332 vials
- Distribution
- Nationwide in the US
- Recall date
- April 10, 2024
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)