FDAFDA · Food and drugs·Recall number D-0141-2023
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.
Published January 25, 2023 · Recall initiated: October 13, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations:
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Akorn, Inc.
- Distributor
- Nationwide in the USA
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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