# Major Recall Alert: Shortage of Fludarabine Phosphate Injection in Canada Prompts US Importation
Healthcare professionals across Canada, particularly in oncology and hematology, should take note of an important update regarding **Fludarabine Phosphate Injection, USP 50mg/2mL (25 mg/mL)**. Due to a shortage of this life-saving drug, **Health Canada** has authorized the **temporary importation and sale of the US-authorized Fludarabine Phosphate Injection** with English-only labels. This measure aims to maintain continuity of care for patients in need of this critical treatment.
Below, we break down the details of this recall, key differences between the Canadian and US products, and what healthcare providers need to do to ensure patient safety.
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## [H2] Why This Recall is Important
Fludarabine Phosphate Injection is a critical medication indicated for the **second-line treatment of adult patients** with **chronic lymphocytic leukemia (CLL)** and **low-grade non-Hodgkin’s lymphoma (Lg-NHL)** when other treatments have failed. The current shortage in Canada threatens to disrupt vital treatments for patients who rely on this medication to manage these conditions.
To address this gap, **Septa Pharmaceuticals Inc.** has been authorized to import US-manufactured Fludarabine Phosphate Injection. While this US product has the same active ingredient, dosage form, and strength as the Canadian version, there are **key differences in labeling, storage, and preparation** that healthcare professionals must carefully review.
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## [H3] Details of the Recall
Here are the **key details** about the authorized temporary importation:
- **Product Name**: Fludarabine Phosphate Injection, USP 50mg/2mL (25 mg/mL)
- **Reason for Recall**: Shortage of the Canadian-authorized product.
- **Authorized Alternative**: US-manufactured Fludarabine Phosphate Injection with English-only labels.
- **Key Differences**:
- The US product includes **additional storage instructions**, such as protecting from light and keeping the vial in its carton.
- Neither product contains antimicrobial preservatives, but unused portions must be discarded after vial puncture.
- Preparation and dilution instructions differ significantly from the Canadian product labeling. Specifically:
- Dilution must be conducted for intravenous infusion in PVC bags with **5% Dextrose Injection USP** or **0.9% Sodium Chloride Injection USP**.
- After dilution, the solution should be used within **8 hours** whether stored at room temperature or refrigerated (2°C to 8°C).
Healthcare professionals should refer to the **Canadian Product Monograph** for further guidance on dosing, contraindications, safety measures, and handling instructions.
[Access the original announcement here.](https://recalls-rappels.canada.ca/en/alert-recall/importation-us-authorized-fludarabine-phosphate-injection-usp-due-current-shortage)
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## [H3] What You Should Do
### Healthcare Professionals:
- **Review Differences in Product Labeling**:
Ensure your practice is aware of the differences in preparation, storage, and labeling between the US and Canadian products.
- **Verify Medication Carefully**:
Double-check the product to avoid confusion with other drugs. The US-authorized product does not feature a Canadian Drug Identification Number (DIN) or a scannable barcode.
- **Follow Correct Dilution Procedures**:
Adhere to compatibility studies and proper guidelines for dilution and infusion preparation, as outlined by Health Canada and the Canadian Product Monograph. This information is NOT provided on the US product labeling.
- **Monitor Patients Closely**:
Continue to report any adverse effects or unexpected reactions related to the US-authorized Fludarabine Phosphate Injection to **Septa Pharmaceuticals Inc.** or **Health Canada**.
### Patients:
- If you are undergoing treatment with Fludarabine Phosphate Injection, it is critical to:
- **Consult with your Healthcare Provider**: Discuss any questions regarding your treatment plan and the temporary drug substitution.
- **Report Side Effects**: Notify your doctor immediately if you experience unusual symptoms.
For adverse effect reporting, contact Septa Pharmaceuticals Inc. at +1 905-564-5665 or visit [MedEffect Canada’s Adverse Reaction Reporting](http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) page for additional reporting methods.
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## [H3] Stay Safe – Get Instant Recall Alerts
Staying informed is critical in maintaining patient safety and ensuring the effective administration of essential medications. **Download our recall notification app today** for real-time updates on drug recalls and shortages in Canada. Never miss a critical safety alert that could impact your practice or your patients.
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### For More Information:
Visit the official source of this recall at [Health Canada’s Recalls and Safety Alerts Database](https://recalls-rappels.canada.ca/en/alert-recall/importation-us-authorized-fludarabine-phosphate-injection-usp-due-current-shortage).