NDC 84549-614
hydrALAZINE Hydrochloride 20 mg per 1 mL injection
On the label: ProPharma Distribution. It's repackaged: ProPharma Distribution rebottles it from Fresenius Kabi, LLC's NDC 63323-614.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi USA, LLC | Melrose Park, IL, United States | Makes it and tests it | Problems found, fixed voluntarilyAug 24, 2023 · 13 inspections, 2 with FDA action |
Repackaging site
- ProPharma Distribution, Westminster, CO, United States · repackages it and relabels it
Recalls
- Mar 8, 2017 · Class II · Mckesson Medical Surgical
Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.
Lots: Lot #s: 6114311, 6114717, Exp 05/18 - Jul 28, 2015 · Class III · Fresenius Kabi USA, LLC
Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
Lots: Lot #: 6110593, Exp 11/2016
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Hydralazine: every company that makes it
- Form
- injection, intramuscular; intravenous
- Strength
- 20 mg per 1 mL
- Approval
- ANDA ANDA040388
- On the market since
- Jan 31, 2011
- Package NDCs
84549-614-55- Official label
- DailyMed (National Library of Medicine), updated Jul 18, 2025
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