Recall Z-0408-2024— EMD Millipore Corporation
Class II · Ongoing
Class II FDA medical device recall by EMD Millipore Corporation, initiated 2023-10-17. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- EMD Millipore Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-17
- Firm location
- Burlington, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.