Reported Jan 25, 2023 · Ongoing
Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 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?
Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles
3 of 3 products
| # | Product as published |
|---|---|
| 1 | NDC 17478-288-11 |
| 2 | (c) 15 mL dropper bottles, NDC 17478-288-12 |
| 3 | Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. |
- Lot codes and dates
- Lot
93 of 93 codes
(a) 0B50A0B69AEXP 1/31/20230C74AEXP 2/28/20230D04AEXP 3/31/20230E37AEXP 4/30/20230G07A0G82AEXP 6/30/20230H26A0H28A0H53A0H36AEXP 7/31/20230J64A0J58A0J66AEXP 8/31/20230K96A0K06A0K98A0K04A0K03A0K99AEXP 9/30/20230L72AEXP 10/31/20230M81A0M85A0M80A0M84A0M82A0M83AEXP 11/30/20231A01A1A02AEXP 12/31/20231B16A1B13A1B17AEXP 1/31/20241C51AEXP 2/29/2024(b) 0B59AEXP 1/31/20230E49AEXP 4/30/20230G14AEXP 6/30/20230H38AEXP 7/31/20230J84AEXP 8/31/20230K05AEXP 9/30/20230L59AEXP 10/31/2023
- Lot
- Amount recalled
- 1,310,324 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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