NDC 0409-1304
Hydromorphone Hydrochloride 4 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
- 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: 760853A - Aug 15, 2012 · Class I · Hospira Inc.
Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume.
Lots: Lot 12720LL, Exp 12/01/13 - May 12, 2012 · Class I · Hospira Inc.
Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume.
Lots: Lot #07547LL, Exp 07/01/13
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Hydromorphone: every company that makes it
- Form
- injection, solution, intramuscular; intravenous; subcutaneous
- Strength
- 4 mg per 1 mL
- Approval
- NDA NDA200403
- On the market since
- Dec 1, 2011
- Package NDCs
0409-1304-030409-1304-31- Official label
- DailyMed (National Library of Medicine), updated Dec 31, 2025
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