Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.
Failed Impurities/Degradation Specifications
Quick Facts at a Glance
- Recall Date
- May 4, 2026
- Hazard Level
- HIGH
- Brands
- BUSULFAN, Sagent Pharmaceuticals
- Geographic Scope
- 1 states
Hazard Information
Failed Impurities/Degradation Specifications
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Sagent Pharmaceuticals or your healthcare provider for guidance. Notification method: Letter
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Full Description
Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.. Generic: BUSULFAN; Brand: BUSULFAN. Reason: Failed Impurities/Degradation Specifications. Classification: Class III. Quantity: Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.. Distribution: Nationwide within the United States
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