Summary
The FDA issued a Class II for Lugol s Iodine Solution 500ML, Part Number 624-71 by EMD Millipore Corporation. 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 .
Details
Source
Device Recall
External ID
Z-0408-2024
Action Date
2023-12-06
Status
Ongoing
Category
device
Product Description
Lugol s Iodine Solution 500ML, Part Number 624-71
Lot/Code Info: Lot Number 3124
Quantity Affected: 5 units
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
US States: CA, NJ, WV
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-17
Company
Burlington, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 190 device recalls issued in the same week, part of 403 device-related FDA actions this month.
EMD Millipore Corporation has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (EMD Millipore Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does EMD Millipore Corporation have FDA actions?
EMD Millipore Corporation has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0408-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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