Iodine Solution Recalled for Improper Bottle Cap Seal
EMD Millipore's Lugol's Iodine Solution (Lot 3124) is recalled due to an improper seal between the cap and bottle, which allows iodine vapors to dissipate and reduces the product's potency over time.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is product potency degradation due to improper seal and iodine vapor dissipation, representing a quality issue rather than an acute safety risk.
Plain-English summary
EMD Millipore Corporation is recalling Lugol's Iodine Solution 500ML, Part Number 624-71, Lot Number 3124. The recall affects 5 units distributed in California, New Jersey, and West Virginia.
The product has an improper seal between the cap and bottle due to incorrect packaging. This defective seal allows iodine vapors to escape, causing the solution's chemical assay to drop below the manufacturer's specification range of 24.8 to 27.2 mL over time.
Users of affected units should contact EMD Millipore Corporation for instructions regarding return or replacement of the product.
The recalled product
- Product
- Lugol s Iodine Solution 500ML, Part Number 624-71
- Manufacturer
- EMD Millipore Corporation
- Category
- Medical Device
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number 3124
Distribution
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