Home / Recalls / Ecometics, Inc. / D-1102-2023

D-1102-2023 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
38,486 vials

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.

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

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

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  • D-1101-2023 Class II — AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufact (August 9, 2023)
  • D-1097-2023 Class II — YAGER'S LINIMENT (Camphor and Turpentine Oil) 3.1% and 8.12% respectively, packa (August 9, 2023)
  • D-0446-2023 Class II — Alcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (207 m (February 24, 2023)
  • D-0451-2023 Class II — Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral (February 24, 2023)
  • D-0452-2023 Class II — Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor (February 24, 2023)
  • 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)