Reported Jan 25, 2023 · Ongoing
GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in…
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?
- GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in Goinoscopic Examinations, Mfd
- byAkorn, INc., Lake Forest, IL 60045
- NDC17478-064-12
- Lot codes and dates
- Lot
0C80AEXP 2/28/20230B71A1B32AEXP 1/31/20230C80BEXP 2/28/20230F68AEXP 5/31/20230G85A0G01A1G54A1G71AEXP 6/30/20230H32A0H47A1H75AEXP 7/31/20230K22AEXP 9/30/20230M90AEXP 11/30/2023
- Lot
- Amount recalled
- 196,254 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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