Medical device recalls Moderate risk

EMD Millipore Corporation recalls Lugol s Iodine Solution 500ML, Part Number 624-71

Recall date
October 17, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0408-2024
FDA classification
Class II
Brand / firm
EMD Millipore Corporation
Sold / distributed
US States: CA, NJ, WV

Why it was 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.

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 Iodine Solution 500ML, Part Number 624-71

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