NDC 39822-0255
Cyclophosphamide 1 g per 50 mL injection, powder, lyophilized, for solution
On the label: XGen Pharmaceuticals DJB, Inc..
Where it's made
This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants XGen Pharmaceuticals DJB, Inc. names for other drugs.
Recalls
- Apr 2, 2024 · Class III · X-Gen Pharmaceuticals Inc.
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'.
Lots: Lot #: CIC2-23001 A, Exp. 11/30/2026
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- 4-Hydroxycyclophosphamide: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous; oral
- Strength
- 1 g per 50 mL
- Approval
- ANDA ANDA211757
- On the market since
- Dec 19, 2023
- Package NDCs
39822-0255-1- Official label
- DailyMed (National Library of Medicine), updated Dec 20, 2024
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