← FDA ENFORCEMENT
D-1102-2023Class II

Ecometics, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Ecometics, Inc.
Product type
Drug
Status
Completed
Report date
2023-08-30
Distribution
Nationwide in the USA
Firm state
CT
Product quantity
38,486 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
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.

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →