Ecometics, Inc.: Drug Recall

Recall #D-1102-2023 · 08/09/2023

Class II: Risk

Recall Details

Recall Number
D-1102-2023
Classification
Class II
Product Type
Drug
Recalling Firm
Ecometics, Inc.
Status
Completed
Date Initiated
08/09/2023
Location
Norwalk, CT, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
38,486 vials

Reason for Recall

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

Product 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.

Distribution Pattern

Nationwide in the USA

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.