NDC 0409-2339
Labetalol Hydrochloride 5 mg per 1 mL injection, solution
On the label: Hospira, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hospira, Inc. | McPherson, KS, United States | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyJan 17, 2025 · 16 inspections, 2 with FDA action |
Recalls
- May 20, 2024 · Class II · Pfizer Inc.
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Lots: Lot#: HJ7566; Exp 2025/05 Lot#: HN8747; Exp 2025/09 Lot#: HN8749; Exp 2025/09
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Labetalol: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 5 mg per 1 mL
- Approval
- ANDA ANDA075239
- On the market since
- Oct 18, 2005
- Package NDCs
0409-2339-240409-2339-34- Official label
- DailyMed (National Library of Medicine), updated May 28, 2021
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?