Lugol s Iodine Solution 500ML, Part Number 624-71
This recall is currently active, issued November 29, 2023. It was issued by Emd Millipore Corporation.
- Company
- Emd Millipore Corporation
- Recall Initiated
- October 17, 2023
- Posted
- November 29, 2023
- Recall Number
- Z-0408-2024
- Quantity
- 5 units
- Firm Location
- Burlington, MA
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Lot Number 3124
Root Cause
Under Investigation by firm
Action Taken
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.