NDC 0409-0125
Labetalol Hydrochloride 5 mg per 1 mL injection, solution
On the label: Hospira, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Pfizer Healthcare India Private Limited | Anakapalli, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyOct 18, 2022 · 7 inspections, 1 with FDA action |
Recalls
- Feb 20, 2018 · Class II · Hospira Inc. A Pfizer Company
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Lots: Lots: a) 74370DD, Exp 1FEB2019; 75035DD, 75115DD, Exp 1MAR2019; b) 74230DD, Exp 1FEB2019 - May 16, 2014 · Class II · Hospira Inc.
Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
Lots: Lot 36225DD, exp 12/01/2015
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 ANDA075240
- On the market since
- Aug 7, 2023
- Package NDCs
0409-0125-010409-0125-25- Official label
- DailyMed (National Library of Medicine), updated Sep 14, 2026
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