NDC 51662-1315
Levophed(R) Norepinephrine Bitartrate 1 mg per 1 mL injection, solution, concentrate
On the label: HF Acquisition Co. LLC. DBA HealthFirst. It's repackaged: HF Acquisition Co. LLC. DBA HealthFirst rebottles it from Hospira, Inc.'s NDC 0409-3375.
Where the pills inside were 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 |
Repackaging site
- HF Acquisition Co LLC, Mukilteo, WA, United States · relabels it
Recalls
- Aug 22, 2017 · Class II · Pfizer Inc.
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Lots: Lot #: 753003A, Exp 9/18; 762153A, 760803A, 761053A , Exp 10/18 - May 18, 2017 · Class II · Hospira Inc., A Pfizer Company
GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
Lots: 720503A, 720603A (Canada only)
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Norepinephrine: every company that makes it
- Form
- injection, solution, concentrate, intravenous
- Strength
- 1 mg per 1 mL
- Approval
- NDA NDA007513
- On the market since
- Oct 18, 2018
- Package NDCs
51662-1315-151662-1315-251662-1315-3- Official label
- DailyMed (National Library of Medicine), updated Feb 5, 2021
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