Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solut...

FDA Drug Recall #D-0434-2024 — Class III — April 2, 2024

Recall Summary

Recall Number D-0434-2024
Classification Class III — Low risk
Date Initiated April 2, 2024
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm X-Gen Pharmaceuticals Inc.
Location Horseheads, NY
Product Type Drugs
Quantity 1332 vials

Product Description

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 DJB, Inc., Big Flats, NY 14814, NDC # 39822-0255-01.

Reason for Recall

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'.

Distribution Pattern

Nationwide in the US

Lot / Code Information

Lot #: CIC2-23001 A, Exp. 11/30/2026

Other Recalls from X-Gen Pharmaceuticals Inc.

Recall # Classification Product Date
D-0433-2024 Class III Cyclophosphamide for Injection, USP, 500mg/vial... Apr 2, 2024
D-0328-2021 Class II Neomycin Sulfate Tablets, USP 500mg, Rx Only, 1... Mar 19, 2021
D-0519-2020 Class III Levetiracetam Injection, 500 mg/5mL, 10 single-... Oct 11, 2019
D-1084-2019 Class III Clonidine HCL Injection, 1000 mcg/10mL (100 mcg... Mar 29, 2019
D-1059-2017 Class II Nystatin Topical Powder, USP, 100,000 USP units... May 17, 2017

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.