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 & CAPAReason 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
Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →Data: U.S. FDA openFDA enforcement API. 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.