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Recall

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 Recall

Failed Impurities/Degradation Specifications Product details: 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.

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Official-source record

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Agency
FDA
Record ID
D-0539-2026
Canonical
https://claimwatch-mvp.vercel.app/item/sagent-pharmaceuticals-busulfan-injection-60-mg-per-10-ml-6-mg-per-ml-8x10-ml-single-dose-/

What happened?

Failed Impurities/Degradation Specifications Product details: 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.

Who may be affected?

Nationwide within the United States

What should consumers do?

Affected quantity: Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.

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FAQ

Is this page official?

No. ClaimWatch links to official sources and marks whether a page is verified or still being monitored.

Is this legal, medical, or financial advice?

No. This page is informational. Always confirm eligibility, deadlines, and safety instructions through official sources.

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