FDA-Drug2023-08-30Class II
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.
Ecometics, Inc.
Hazard
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Sold states
Nationwide in the USA
Affected count
38,486 vials
Manufactured in
19 Concord St, N/A, Norwalk, CT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1102-2023Don't want to check this manually?
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