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
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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