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- Recall Enforcement Event ID: 91719
Recall Enforment Report D-0450-2023
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Ecometics, Inc., originally initiated on 02-24-2023 for the product Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in 0.46 oz. (13g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756 The product was recalled due to cgmp deviations. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
---|---|---|---|---|---|---|---|
D-0450-2023 | 02-24-2023 | 03-15-2023 | Class II | 37,968 metal tube/folding carton | Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in 0.46 oz. (13g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756 | CGMP DEVIATIONS | Terminated |
D-0452-2023 | 02-24-2023 | 03-15-2023 | Class II | Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%), packaged in 1 oz. (28.3g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756 | CGMP DEVIATIONS | Terminated | |
D-0451-2023 | 02-24-2023 | 03-15-2023 | Class II | 34,320 bottles | 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 | CGMP DEVIATIONS | Terminated |
D-0449-2023 | 02-24-2023 | 03-15-2023 | Class II | a) 23,993 plastic jar/folding carton and b) 34,284 plastic jar/folding carton | Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) plastic jars and b) 3 Oz (85g) plastic jars | CGMP DEVIATIONS | Terminated |
D-0446-2023 | 02-24-2023 | 03-15-2023 | Class II | 18,000 bottles | Alcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (207 ml) and b) 16 fluid oz. (472 ml) bottles, Distributed by: The Larkspur Group Inc. South Norwalk, CT 06854 | CGMP DEVIATIONS | Terminated |
D-0448-2023 | 02-24-2023 | 03-15-2023 | Class II | 20,746 metal tubes/folding cartons | Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%) packaged in 1 oz. (28g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756 | CGMP DEVIATIONS | Terminated |
D-0447-2023 | 02-24-2023 | 03-15-2023 | Class II | 4,210 metal tubes/folding carton | Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed by: The Larkspur Group Inc. Norwalk, CT 06854 | CGMP DEVIATIONS | Terminated |