Recall D-1102-2023
Description: Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single Use Vials, Rx Only, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6064-0, Ref 6064.
Recall D-1102-2023 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-1102-2023 |
Event ID | 92857 |
Distribution | Nationwide in the USA |
Quantity | 38,486 vials |
Recall Reason | CGMP Deviations: Products not manufactured under current good manufacturing practices. |
Drug Classification | Class II |
Drug Code Info | 20230830 |
Recall Initiation Date | 20230809 |
Report Date | 20230830 |
Classification Date | 20230824 |
Address | 19 Concord St Norwalk, CT 06854-3706 United States |
Recalling Firm | Ecometics, Inc. |
Initial Notification | Letter |
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