The Recall Desk

FDA (Drugs) recall action 92857

Ecometics, Inc. recalled 7 products on 2023-08-30

The FDA (Drugs) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.

Products
7
Announced
2023-08-30
Critical
0
Units
164,036

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–7 of 7

  • ModerateFDA (Drugs)··2023-08-30

    ALCOLADO RELAMPAGO topical liniment recalled for manufacturing process violations

    Ecometics, Inc. is recalling ALCOLADO RELAMPAGO (menthol and camphor) topical liniment nationwide due to manufacturing process deviations. Products were not manufactured under current good manufacturing practices.

    Product
    ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged in a 7 FLUID OZ (207 ml) bottles, UPC 7 18864 20102 9 and b) 16 FLUID OZ (472 ml) bottles, UPC 7 18864, 20110 4, Distributed by: The Larkspur Group, Inc., Norwalk, CT 06854.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2023-08-30

    Blis-To-Sol Tolnaftate Liquid Recalled for Manufacturing Practice Deviations

    Ecometics, Inc. is recalling Blis-To-Sol Liquid (Tolnaftate) nationwide due to manufacturing practice violations. No illnesses have been reported.

    Product
    Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottles, UPC 0 11169 20011 8 and b) 1.85 FLUID OZ. (54.5 mL) bottles, UPC 0 11169 20012 5, Distributed by Oakhurst Company, Levittown, NY 11756.
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-08-30

    Lugol's Strong Iodine Solution Recalled Due to Manufacturing Quality Deviations

    Ecometics, Inc. is recalling Lugol's Strong Iodine Solution nationwide due to manufacturing quality deviations. Consumers with affected prescription vials should consult their healthcare provider.

    Product
    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.
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-08-30

    FDA Recalls AstrinGyn Surgical Hemostatic Due to Manufacturing Practice Deviations

    Ecometics is recalling 92,967 vials of AstrinGyn (Ferric Subsulfate) Aqueous due to manufacturing practice violations. The product was not manufactured under current good manufacturing practices (CGMP).

    Product
    AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065.
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-08-30

    Sodium Fluoride Activator Concentrate Recalled for Manufacturing Practice Violations

    Ecometics, Inc. is recalling 32,583 bottles of Sodium Fluoride 0.96% Activator Concentrate nationwide due to manufacturing practice deviations. The product was not manufactured under current good manufacturing practices (CGMP).

    Product
    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2023-08-30

    Unguentine Ointment Recalled Due to Manufacturing Practice Deviations

    Ecometics, Inc. is recalling Unguentine Ointment because products were not manufactured under current good manufacturing practices. The recall affects 6,660 tubes distributed nationwide.

    Product
    Unguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide 6.6%), labeled as a) NET WT 1 OZ (28 g) tubes, Improved Formula, UPC 0 11169 10216 0, and b) NET WT 1 OZ (28.3g) tubes, Maximum Strength, UPC 0 11169 11250 3, Distributed by: Oakhurst Company, Levittown
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-08-30

    Yager's Liniment Recalled for Manufacturing Practice Violations

    Ecometics recalls Yager's Liniment due to manufacturing practice violations affecting products nationwide.

    Product
    YAGER'S LINIMENT (Camphor and Turpentine Oil) 3.1% and 8.12% respectively, packaged in a) 4 FL OZ (118 mL) bottles, UPC 0 11169 00004 6, and 8 FL OZ (236 mL) bottles, UPC 0 11169 00008 4, The Oakhurst Co., Dist., Levittown, NY 11756.
    Category
    Distribution
    0 states