NDC 63187-628
Ketorolac Tromethamine 5 mg per 1 mL solution
On the label: Proficient Rx LP. It's repackaged: Proficient Rx LP 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 |
Repackaging site
- Proficient Rx LP, Thousand Oaks, CA, United States · relabels it
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, ophthalmic
- Strength
- 5 mg per 1 mL
- Approval
- ANDA ANDA078434
- On the market since
- Nov 5, 2009
- Package NDCs
63187-628-05- Official label
- DailyMed (National Library of Medicine), updated Jun 1, 2021
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