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U.S. Department of Health and Human Services

Class 2 Device Recall Lugol's Iodine Solution

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  Class 2 Device Recall Lugol's Iodine Solution see related information
Date Initiated by Firm October 17, 2023
Date Posted November 29, 2023
Recall Status1 Open3, Classified
Recall Number Z-0408-2024
Recall Event ID 93318
Product Classification Solution, lugol's - Product Code IAM
Product Lugol s Iodine Solution 500ML, Part Number 624-71
Code Information Lot Number 3124
Recalling Firm/
Manufacturer		 EMD Millipore Corporation
400 Summit Dr
Burlington MA 01803-5258
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action A Product Recall notification letter dated 10/17/23 was sent to customers. Required/Recommended Action Please immediately examine your inventory to determine if you have any remaining impacted product and forward a copy of this letter to the personnel in your organization that utilize this product and/or need to be made aware of this issue. Please discard this material and request a replacement. Please complete attachment 1 form acknowledging receipt of this letter and return to the noted email address. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this issue. Your notification to customers should include a copy of this notification. You may contact Technical or Customer Service to discuss an appropriate solution for your needs. If you would like more information about this FCA notification, please contact your local representative or use the link www.sigmaaldrich.com/offices for our website to obtain the phone number and/or email address of your local office.
Quantity in Commerce 5 units
Distribution US States: CA, NJ, WV
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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