NDC 64725-1782
Naloxone Hydrochloride 0.4 mg per 1 mL injection, solution
On the label: TYA Pharmaceuticals. It's repackaged: TYA Pharmaceuticals rebottles it from Hospira, Inc.'s NDC 0409-1782.
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
- TYA Pharmaceuticals, Location not on file · repackages it and relabels it
Recalls
- Jun 4, 2018 · Class I · Hospira Inc, Lake Forest
Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
Lots: 72680LL, Exp. 1DEC2018 (NDC 0409-1782-03); 76510LL, Exp. 1APR2019 (NDC 0409-1782-69)
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Naloxone: every company that makes it
- Form
- injection, solution
- Strength
- 0.4 mg per 1 mL
- Approval
- ANDA ANDA070172
- On the market since
- Sep 24, 1986
- Package NDCs
64725-1782-9- Official label
- DailyMed (National Library of Medicine), updated Oct 23, 2013
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