Ecometics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
14
510(k) Clearances
0
Inspections
7
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-1097-2023Class IIYAGER'S LINIMENT (Camphor and Turpentine Oil) 3.1% and 8.12% respectively, packaged in a) 4 FL OZ (1August 9, 2023
D-1102-2023Class IILugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8August 9, 2023
D-1099-2023Class IIUnguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide 6.6%), labeled as a) NAugust 9, 2023
D-1098-2023Class IIALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged in a 7 FLUID OZ (207 mlAugust 9, 2023
D-1096-2023Class IIBlis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottles, UPC 0 11169 20011August 9, 2023
D-1100-2023Class IIactivator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% in diluted Activator SoAugust 9, 2023
D-1101-2023Class IIAstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgiAugust 9, 2023
D-0446-2023Class IIAlcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (207 ml) and b) 16 fluid oFebruary 24, 2023
D-0452-2023Class IIUnguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, February 24, 2023
D-0449-2023Class IISoltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) plastic jars and b) 3 OzFebruary 24, 2023
D-0448-2023Class IIUnguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%) pacFebruary 24, 2023
D-0447-2023Class IIVencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed by: The Larkspur Group IFebruary 24, 2023
D-0450-2023Class IINose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in 0.46 oz. (13g) metal tuFebruary 24, 2023
D-0451-2023Class IIActivator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral rinse plastic bottlFebruary 24, 2023