Reported Jan 25, 2023 · Ongoing
Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL…
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?
- Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only
- Manufactured byAkorn, Inc., Lake Forest, IL 60045
- Distributed byMWI, Boise, ID 83705. NDC 13985-604-05
- Lot codes and dates
- Lot
1D94AEXP 3/31/20231E35AEXP 4/30/20232A06AEXP 12/31/2023
- Lot
- Amount recalled
- 91,692 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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