Recall archive / FDA device enforcement
Lugol s Iodine Solution 500ML, Part Number 624-71 — FDA record Z-0408-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 17, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- EMD Millipore Corporation
- Quantity
- 5 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0408-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot Number 3124 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US States: CA, NJ, WV
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 6, 2023
- Recall initiation date
- Oct 17, 2023
- Center classification date
- Nov 29, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.