RecallRadar

FDA Drug recall D-1102-2023

Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single Use Vials, Rx Only, Manufactu…

On 2023-08-30 the FDA classified a Class II recall of Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single Use Vials, Rx Only, Manufactu… by Ecometics, citing CGMP Deviations: Products not manufactured under current good manufacturing practices.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1102-2023
ClassificationClass II
Statuscompleted
Initiated2023-08-09
Published2023-08-30
Last updated2026-09-13 11:52 UTC
CompanyEcometics
DistributionUS

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

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

Identifiers

code_infoLot #: 2E235A, exp: 2/2024; 2E293A, exp: 3/2024

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1102-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.