Recall D-0539-2026

US Class III Ongoing · initiated 2026-05-04

Recalling firm

Sagent Pharmaceuticals, IL

Product

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.

Reason for recall

Failed Impurities/Degradation Specifications

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