Recall Enforment Report D-0609-2024

Recall Details

Multi event Drug Recall Enforcement Report Class I voluntary initiated by Homeocare Laboratories, Inc., originally initiated on 06-05-2024 for the product STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 22875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-121-01 The product was recalled due to microbial contamination of non-sterile products: multiple bacillus species organisms. 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-0609-202406-05-202407-24-2024Class I31,811 x 1 fl. oz. spray bottleSTELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 22875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-121-01Microbial Contamination of Non-Sterile Products: multiple Bacillus species organismsTerminated
D-0610-202406-05-202407-24-2024Class II31,110 x 16 fl. oz. bottleSTELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473 ml), Distributed by: StellaLife, 2875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-143-16Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organismTerminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
69685-121Stellalife Vega Oral Care Pain and Swelling ReliefArnica, Calendula, Chamomilla, Echinacea Angustifolia, Echinacea Purpurea, Hepar Sulph Calc, Hypericum, Lgnatia, Ruta, StaphysagriaSprayTopicalStellalife, Inc.Human Otc Drug
69685-143Stellalife Vega Oral Care Peppermint Advanced Healing FormulaAzadirachta Indica, Calendula, Echinacea Purpurea, Plantago MajorRinseOralStellalife, Inc.Human Otc Drug