NDC 63323-161
Ketorolac Tromethamine 15 mg per 1 mL injection, solution
On the label: Fresenius Kabi, LLC.
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
- Dec 23, 2020 · Class I · Fresenius Kabi USA, LLC
Presence of Particulate Matter - found in reserve sample vials at the firm.
Lots: Lot # 6121083, Exp 2/2021 - Dec 17, 2020 · Class II · Fresenius Kabi USA, LLC
Presence of Particulate Matter - found in reserve sample vials at the firm.
Lots: Batch # 6121125, Exp 02/2021 - Apr 20, 2020 · Class I · Fresenius Kabi USA, LLC
Presence of Particulate Matter - found in reserve sample vials at the firm.
Lots: Lot #: 6118737, 6118902, Exp 04/2020; 6119052, Exp 05/2020; 6119752, Exp 08/2020; 6122349, Exp 07/2021; 6122538, Exp 09/2021 - Apr 20, 2020 · Class II · Fresenius Kabi USA, LLC
Presence of Particulate Matter - found in reserve sample vials at the firm.
Lots: Lot #: 6119229, 6119273, Exp 06/2020; 6119843, Exp 09/2020; 6121115, Exp 02/2021; 6121451, 6121452, 6121496, Exp 03/2021
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, solution, intramuscular; intravenous
- Strength
- 15 mg per 1 mL
- Approval
- ANDA ANDA075784
- On the market since
- Sep 5, 2001
- Package NDCs
63323-161-0063323-161-01- Official label
- DailyMed (National Library of Medicine), updated Jul 23, 2024
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