NDC 0409-2634
Hydromorphone Hydrochloride 10 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
- Feb 7, 2018 · Class I · Pfizer Inc.
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Lots: Lot 71330DD EXP. 11/1/2018. - Jul 26, 2017 · Class II · Hospira Inc, Lake Forest
Presence of Particulate Matter: Silicone oil
Lots: Lot #: 56260DD, Exp. 01AUG2017 - Oct 1, 2014 · Class II · Hospira Inc.
Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.
Lots: Lot #: a) 260753F, 261403F, Exp 1FEB2015; 290153F, Exp 1MAY2015; b) 24-080-DD, Exp 1DEC2014; 25-475-DD, Exp 1JAN2015
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
- 10 mg per 1 mL
- Approval
- ANDA ANDA078591
- On the market since
- Jul 31, 2008
- Package NDCs
0409-2634-010409-2634-050409-2634-100409-2634-250409-2634-50- Official label
- DailyMed (National Library of Medicine), updated Apr 21, 2026
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