Class III · Low risk
Lugol's (Strong Iodine Solution USP)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
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.
Affected NDC
59365-6064-00
Compare with the code on your package — it is the most precise check available.
Drug: Iodine
- Recalling firm
- Ecometics, Inc.
- NDC code
- 59365-6064-0
- Origin
- CT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1102-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now completed, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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Class II · Moderate risk
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Class II · Moderate risk
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Class II · Moderate risk
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