United StatesBusulfan Injection, 60 mg per 10 mL (6 mg/mL) in 8×10 mL single‑dose vials (NDC 25021-241-10) made for Sagent Pharmaceuticals and manufactured in Canada is affected, specifically lot 656412 (exp. 08/31/2026) and lot 659646 (exp. 03/31/2027), distributed nationwide in the United States. The product was recalled because the lots failed impurities/degradation specifications.
What's being recalled
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.
Recalling firm: Sagent Pharmaceuticals, Schaumburg, IL, United States.
How to identify it
Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
The hazard
Failed Impurities/Degradation Specifications
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within the United States
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)