Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi USA, LLC | Grand Island, NY, United States | Makes it and tests it | Problems found, fixed voluntarilyOct 13, 2023 · 14 inspections, 2 with FDA action |
| 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 |
Recalls
- Jun 24, 2013 · Class II · Fresenius Kabi USA, LLC
Subpotent Drug; 15-month stability test station
Lots: Lot #: 6003648, Exp. 6/2013
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Oxytocin: every company that makes it
- Form
- injection, solution, intramuscular; intravenous
- Strength
- 10 [USP'U] per 1 mL
- Approval
- NDA NDA018248
- On the market since
- Aug 10, 2000
- Package NDCs
63323-012-0263323-012-0363323-012-0663323-012-1063323-012-1163323-012-30- Official label
- DailyMed (National Library of Medicine), updated Jan 12, 2026
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