NDC 0641-6043
Ketorolac Tromethamine 30 mg per 1 mL injection
On the label: Hikma Pharmaceuticals USA Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hikma Pharmaceuticals USA Inc. | Cherry Hill, NJ, United States | Makes it, tests it and labels it | No problems foundMay 13, 2026 · 18 inspections |
Recalls
- Dec 17, 2019 · Class II · Hikma Pharmaceuticals USA Inc.
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Lots: 038368, Exp. Mar 2020; 058314, Exp. May 2020; 078305, 078307, Exp. July 2020; 118362 Exp. Nov 2020 - Dec 17, 2019 · Class I · Hikma Pharmaceuticals USA Inc.
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Lots: Lot #: 038366, Exp. Date Mar 2020; 048365, 048367, Exp. Date Apr 2020; 078301, 078303, Exp. Date July 2020; 118358, Exp. Date Nov 2020; 029353, Exp. Date Feb 2021; 019413, Exp. Date Jan 2021
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ketorolac: every company that makes it
- Form
- injection, intramuscular
- Strength
- 30 mg per 1 mL
- Approval
- ANDA ANDA075772
- On the market since
- Jul 21, 2004
- Package NDCs
0641-6043-010641-6043-25- Official label
- DailyMed (National Library of Medicine), updated Apr 10, 2024
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