FDAClass IIAugust 30, 2023

Lugol's recall: CGMP Deviations

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…

Why was Lugol's recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 2E235A, exp: 2/2024; 2E293A, exp: 3/2024

Product
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…
Recalling firm
Ecometics, Inc.
Quantity
38,486 vials
Distribution
Nationwide in the USA
Recall date
August 30, 2023
Classification
Class II
Status
Completed
Agency
FDA (drug)
Open FDA enforcement record Latest recalls