FDAFDA · Food and drugs·Recall number D-1102-2023
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.
Published August 30, 2023 · Recall initiated: August 9, 2023
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Products not manufactured under current good manufacturing practices.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ecometics, Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot #: 2E235A, exp: 2/2024; 2E293A, exp: 3/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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