Drug & medication recalls Moderate risk

Lugol's recalled over manufacturing violations

Recall date
August 9, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Ecometics, Inc. recalls Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single Use Vials…
Recall number
D-1102-2023
FDA classification
Class II
Brand / firm
Ecometics, Inc.
Sold / distributed
Nationwide in the USA

Why it was recalled

CGMP Deviations: Products not manufactured under current good manufacturing practices.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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.

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