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Sagent Pharmaceuticals: 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

DrugsSource: FDA (drug) · Date: 2026-05-27

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Sagent Pharmaceuticals
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 / hazard
Failed Impurities/Degradation Specifications
Classification
Class III
Status
Ongoing
Distribution / sold at
Nationwide within the United States
Recall initiated
2026-05-04
Code info
Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
Product quantity
Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.
Voluntary mandated
Voluntary: Firm initiated
City
Schaumburg
State
IL
Country
United States
Event id
98883
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