FDAClass IIDecember 6, 2023

Lugol s Iodine Solution recall

Lugol s Iodine Solution 500ML, Part Number 624-71

Why was Lugol s Iodine Solution recalled?

Due to the incorrect packaging utilized with lot 3124, there' s an improper seal between the cap and bottle. With an improper seal the Assay (current specification of 24.8 to 27.2 mL) is expected to continue to drop over time as iodine vapors continue to dissipate from the bottles.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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 Number 3124

Product
Lugol s Iodine Solution 500ML, Part Number 624-71
Recalling firm
EMD Millipore Corporation
Quantity
5 units
Distribution
US States: CA, NJ, WV
Recall date
December 6, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls