Product Wiki · Recalls · U.S. FDA — Device Enforcement

Lugol s Iodine Solution 500ML, Part Number 624-71 — recall Z-0408-2024

U.S. FDA — Device Enforcement · United States · 2023-10-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0408-2024
Date of alert
2023-10-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
EMD Millipore Corporation
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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