FDA recall Z-0408-2024

Product

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

Reason for recall

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.

Distribution

US States: CA, NJ, WV

Key facts

Status

Ongoing

Initiation date

2023-10-17

Report date

2023-12-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Burlington, MA, United States

Primary source

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