Home / Recalls / Ecometics, Inc. / D-1098-2023

D-1098-2023 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
a) 52,879 bottles; b) 12,054 bottles

Product Description

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.

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

a) 0E280A, exp 10/23; 0E318A, exp 11/23; 1E109A, exp 3/24; 1E141A, exp 5/24; b) 0E280A, exp 11/23; 1E109A, 1E141A, exp 3/24

Other recalls by Ecometics, Inc.

  • D-1102-2023 Class II — Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassi (August 9, 2023)
  • D-1099-2023 Class II — Unguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide 6. (August 9, 2023)
  • D-1096-2023 Class II — Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottle (August 9, 2023)
  • 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)
  • 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)