Reported Aug 30, 2023 · Completed
Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single Use…
Ecometics, 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: Ecometics, Inc. · 19 Concord St · Norwalk, CT · 06854-3706
Is this the product you have?
- Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single Use Vials, Rx Only, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6064-0, Ref 6064.
- Lot codes and dates
- Lot #: 2E235A
- exp
2/20242E293A
- exp3/2024
- Amount recalled
- 38,486 vials
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Products not manufactured under current good manufacturing practices.
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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