Home / Recalls / Ecometics, Inc. / D-1100-2023

D-1100-2023 Class II

Recalled by Ecometics, Inc. — Norwalk, CT

Recall Details

Product Type
Drugs
Report Date
August 30, 2023
Initiation Date
August 9, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
32,583 bottles

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.

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

Lot: 1E175B, exp 6/24

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  • D-0452-2023 Class II — Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor (February 24, 2023)
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