Class II · Moderate risk Ongoing
Dexamethasone Moxifloxacin Ketorolac
Reason Presence of particulate matter - Glass like particles.
Ketorolac Tromethamine Ophthalmic Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations:
What was recalled
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL dropper bottle, NDC 17478-209-19; (c) 5 mL dropper bottle, NDC 17478-209-10; Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.
- Recalling firm
- Akorn, Inc.
- NDC code
- 17478-209-11
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0141-2023
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Ketorolac recalls
See all
Class II · Moderate risk Ongoing
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac…
Reason Incorrect Product Formulation
Class II · Moderate risk Ongoing
R.E.C.K.
Reason Presence of Particulate Matter
Class II · Moderate risk Ongoing
Ketorolac Tromethamine Injection
Reason Presence of Particulate Matter: Particulate matter identified as glass
Class II · Moderate risk Ongoing
Ketorolac Tromethamine Ophthalmic Solution
Reason Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.