Recall Enforment Report D-0884-2023

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Homeocare Laboratories, Inc., originally initiated on 06-05-2023 for the product DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15 The product was recalled due to cgmp deviations. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0884-202306-05-202307-05-2023Class II12,850 tottlesDoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15cGMP deviationsOngoing
D-0887-202306-05-202307-05-2023Class II16,587 bottlesStellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distributed by: StellaLife, Aventura, FL NDC 69685-113-16cGMP deviationsOngoing
D-0886-202306-05-202307-05-2023Class II130,762/16 oz. tottlesStellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-103-16cGMP deviationsOngoing
D-0888-202306-05-202307-05-2023Class II40,034/1 fl. oz tubesStellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-101-02cGMP deviationsOngoing
D-0882-202306-05-202307-05-2023Class II5,956 bottlesBebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distributed by Pharmadel LLC Georgetown, DE NDC 55758-036-01cGMP deviationsOngoing
D-0885-202306-05-202307-05-2023Class II200 liters/55 gallon drumSnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99cGMP deviationsOngoing
D-0881-202306-05-202307-05-2023Class II2,376 bottlesArnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New York, NY 10021 UPC 8 60208 00181 6cGMP deviationsOngoing
D-0883-202306-05-202307-05-2023Class II5957 bottlesBabelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-035-01cGMP deviationsOngoing
D-0889-202306-05-202307-05-2023Class II38,105/1 fl. oz. tubesStellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-102-02cGMP deviationsOngoing
D-0880-202306-05-202307-05-2023Class II921 bottlesKanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufactured For: Acutens, Inc., Sheridan, WY NDC 80551-201-02cGMP deviationsOngoing
D-0890-202306-05-202307-05-2023Class II33,109/1 fl. oz. tubesStellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-112-01cGMP deviationsOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
55758-001Doloear Atropa Belladonna, Apis Mellifera, Aristolochia Clematitis Root, Matricaria Recutita, Lachesis Muta Venom, And Thuja Occidentalis Leafy TwigSolution/ DropsAuricular (otic)Pharmadel LlcHuman Otc Drug
61152-199Snorestop Nasospray 60 Strychnos Nux-vomica Seed,atropa Belladonna,ephedra Distachya Flowering Twig,goldenseal,potassium Dichromate,teucrium Marum,histamine Dihydrochloride LiquidLiquidNasalGreen Pharmaceuticals Inc.Human Otc Drug
69685-103Stellalife Vega Oral Care Rinse RinseRinseDentalStellalife, Inc.Human Otc Drug
69685-111Stellalife Vega Oral Care SpraySprayDental; SublingualStellalife, Inc.Human Otc Drug
69685-112Stellalife Vega Oral Care Gel GelGelDental; TopicalStellalife, Inc.Human Otc Drug
69685-113Stellalife Vega Oral Care Coconut RisneRinseDentalStellalife, Inc.Human Otc Drug
69685-115Stellalife Vega Oral Care Recovery KitKitDental; Sublingual; TopicalStellalife, Inc.Human Otc Drug
80551-201Kanjo Homeopathic Pain Relief Cream Homeopathic Pain Relief CreamCreamTopicalAcutensHuman Otc Drug