Baxter Deutschland GmbH
Bielefeld, Germany · makes the active ingredient
Problems found, fixed voluntarily Last FDA inspection May 28, 2025. 5 inspections on record.
NDC 10019-079
Bendamustine Hydrochloride 100 mg injection
On the label: Baxter Healthcare Corporation.
Where it's made
Recalls
- Aug 14, 2023 · Class III · Completed
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Lots: Lots: 3A004A, 3A004B, Exp 12/31/2024; 3B005A, Exp 1/31/2025
Product details
- Generic drug
- Bendamustine: see every company that makes it
- Form
- injection, intravenous
- Strength
- 100 mg
- Approval
- NDA NDA216078
- On the market since
- Dec 15, 2022
- Package NDCs
10019-079-01- Official label
- DailyMed (National Library of Medicine), updated Feb 10, 2025
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