FDA Enforcement
Class II
Ongoing
Lugol s Iodine Solution 500ML, Part Number 624-71
Recall: Z-0408-2024
·
Reported December 6, 2023
Enforcement
- Recall Number
- Z-0408-2024
- Event ID
- 93318
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- EMD Millipore Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 6, 2023
- Initiation Date
- October 17, 2023
- Classification Date
- November 29, 2023
- Address
- 400 Summit Dr, Burlington, MA, 01803-5258, United States
Description
Lugol s Iodine Solution 500ML, Part Number 624-71
Reason
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.
Code Info
Lot Number 3124
Distribution
US States: CA, NJ, WV
Quantity
5 units