Z-0408-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 6, 2023
- Initiation Date
- October 17, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product Description
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 Pattern
US States: CA, NJ, WV
Code Information
Lot Number 3124