FDA DrugClass IIINotable

FDA Recall: Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sage

Date: 2026-05-27
Brand: Sagent Pharmaceuticals
Category: Drug
FDA Class: Class III

Description

Failed Impurities/Degradation Specifications

Hazard

Failed Impurities/Degradation Specifications

Remedy

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

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