NDC 16590-376
Ketorolac Tromethamine 5 mg per 1 mL solution
On the label: Stat Rx USA. It's repackaged: Stat Rx USA rebottles it from Akorn's NDC 17478-209.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Akorn | Location not on file | Makes it and tests it | Not inspected on record |
Recalls
- Oct 13, 2022 · Class II · Akorn, Inc.
CGMP Deviations:
Lots: Lot: (a) 1A09A, EXP 12/31/2022; 1H01A, EXP 7/31/2023 ; (b) 1E32A, EXP 4/30/2023; 1F45A, EXP 5/31/2023; 1H99A, EXP 7/31/2023; 1K84A, EXP 9/30/2023; (c) 0L40A, EXP 10/31/2022; 1B38A, EXP 1/31/2023; 1E12A, EXP 4/30/2023; 1F41A, EXP 5/31/2023; 1G73A, 1G68A, EXP 6/30/2023; 1H08A, 1H12A, EXP 7/31/2023
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
- solution
- Strength
- 5 mg per 1 mL
- Approval
- ANDA ANDA078434
- On the market since
- Nov 5, 2009
- Package NDCs
16590-376-0316590-376-05- Official label
- DailyMed (National Library of Medicine), updated Nov 30, 2011
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?