← FDA ENFORCEMENT
D-1100-2023Class 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
32,583 bottles
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

activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% in diluted Activator Solution, Net 1 FL. OZ., Manufactured for: All USA Direct, LLC, Broadview, IL 60155.

Code / lot info

Lot: 1E175B, exp 6/24

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 →