NDC 18657-117
HYLENEX Recombinant 150 [USP'U] per 1 mL injection, solution
On the label: Antares Pharma, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Patheon Manufacturing Services LLC | Greenville, NC, United States | Makes it | No problems foundSep 26, 2025 · 11 inspections |
Recalls
- Sep 11, 2024 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP Deviations: Temperature excursion
Lots: Serial # 100000831961 100000820688 100000820689 100000820515
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Hyaluronidase (human Recombinant): every company that makes it
- Form
- injection, solution, subcutaneous
- Strength
- 150 [USP'U] per 1 mL
- Approval
- BLA BLA021859
- On the market since
- Dec 2, 2005
- Package NDCs
18657-117-0118657-117-0218657-117-04- Official label
- DailyMed (National Library of Medicine), updated Nov 11, 2024
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