FDA-Device2023-12-06Class II

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

EMD Millipore Corporation
Hazard

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.

Sold states
US States: CA, NJ, WV
Affected count
5 units
Manufactured in
400 Summit Dr, Burlington, MA, United States
Products
Lugol s Iodine Solution 500ML, Part Number 624-71

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0408-2024

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