Ketorolac Tromethamine Ophthalmic Solution recall: CGMP Deviations
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.
Why was Ketorolac Tromethamine Ophthalmic Solution recalled?
CGMP Deviations:
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 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.
- Quantity
- 314,543 10ml,3ml, 5ml bottles
- Distribution
- Nationwide in the USA
- Recall date
- January 25, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)