Reported Jan 25, 2023 · Ongoing
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL…
Akorn, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Akorn, Inc. · 5605 Centerpoint Ct Ste A · Gurnee, IL · 60031-5278
Is this the product you have?
4 of 4 products
| # | Product as published |
|---|---|
| 1 | Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11 |
| 2 | (b) 3 mL dropper bottle, NDC 17478-209-19 |
| 3 | (c) 5 mL dropper bottle, NDC 17478-209-10 |
| 4 | Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. |
- Lot codes and dates
- Lot
(a) 1A09AEXP 12/31/20221H01AEXP 7/31/2023(b) 1E32AEXP 4/30/20231F45AEXP 5/31/20231H99AEXP 7/31/20231K84AEXP 9/30/2023(c) 0L40AEXP 10/31/20221B38AEXP 1/31/20231E12AEXP 4/30/20231F41AEXP 5/31/20231G73A1G68AEXP 6/30/20231H08A1H12AEXP 7/31/2023
- Lot
- Amount recalled
- 314,543 10ml,3ml, 5ml bottles
This recall covers 27 products
The agency filed one notice per product. You are reading one of them; the other 26 are below.
14 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations:
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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