Drug 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.
D-0539-2026
Product summary
- Event
- Event 98883
- Status
- Ongoing
- Classification
- Class III
- Quantity
- Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.
- Official record key
drug-enforcement:D-0539-2026
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications