Reported Jan 25, 2023 · Ongoing
Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake…
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?
- Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube
- Manufactured byAkorn, Inc., Lake Forest, IL 60045
- NDC17478-622-35
- Lot codes and dates
- Lot
0F69AEXP 5/31/20230G92B0G92AEXP 6/30/20230J69AEXP 8/31/20230K29A0K24AEXP 9/30/20230M93A0M92A0M92BEXP 11/30/20231B25AEXP 1/31/20241C74AEXP 2/29/20241E19AEXP 4/30/20241C77AEXP 2/29/2024
- Lot
- Amount recalled
- 524,506 tubes
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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