FDA recall D-1102-2023

Ecometics, Inc. · Class II · drug

Product

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.

Reason for recall

CGMP Deviations: Products not manufactured under current good manufacturing practices.

Distribution

Nationwide in the USA

Key facts

Status: Completed
Initiation date: 2023-08-09
Report date: 2023-08-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Norwalk, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1102-2023