Home / Recalls / Ecometics, Inc. / D-0451-2023

D-0451-2023 Class II Terminated

Recalled by Ecometics, Inc. — Norwalk, CT

Recall Details

Product Type
Drugs
Report Date
March 15, 2023
Initiation Date
February 24, 2023
Termination Date
June 21, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
34,320 bottles

Product Description

Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral rinse plastic bottles, Manufactured for: All USA Direct LLC, Broadview, IL 60155

Reason for Recall

CGMP DEVIATIONS

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 2E055A, Exp. Date Feb-2025

Other recalls by Ecometics, Inc.

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  • D-1100-2023 Class II — activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% in (August 9, 2023)
  • D-1101-2023 Class II — AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufact (August 9, 2023)
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  • D-0449-2023 Class II — Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) plas (February 24, 2023)
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