Homeocare Laboratories, Inc.

FDA Regulatory Profile

Homeocare Laboratories, Inc. appears in FDA public data with 13 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 5 FDA inspections, and 2 compliance actions on record. Its most recent recall (D-0609-2024, Class I) was initiated on Jun 5, 2024. Its most recent FDA inspection ended on Mar 20, 2024 (Official Action Indicated (OAI)).

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Summary

Total Recalls
13 (1 Class I)
510(k) Clearances
0
Inspections
5
Compliance Actions
2

Recent Recalls

NumberClassProductDate
D-0609-2024Class ISTELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 2Jun 5, 2024
D-0610-2024Class IISTELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473 ml), Distributed by: SJun 5, 2024
D-0882-2023Class IIBebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distributed by Pharmadel LLC GeorJun 5, 2023
D-0881-2023Class IIArnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New York, NY 10021 UPC 8 602Jun 5, 2023
D-0884-2023Class IIDoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758Jun 5, 2023
D-0880-2023Class IIKanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufactured For: Acutens, IJun 5, 2023
D-0889-2023Class IIStellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaLife, Inc., Aventura, FLJun 5, 2023
D-0886-2023Class IIStellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by: StellaLife, Jun 5, 2023
D-0885-2023Class IISnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99Jun 5, 2023
D-0887-2023Class IIStellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distributed by: StellaLife, AveJun 5, 2023
D-0888-2023Class IIStellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, Inc., AventuraJun 5, 2023
D-0890-2023Class IIStellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed by: StellaLife, Inc., Jun 5, 2023
D-0883-2023Class IIBabelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel LLCJun 5, 2023

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 20, 2024Yonkers, NYDrugsOfficial Action Indicated (OAI)3008420443
Feb 21, 2023Yonkers, NYDrugsOfficial Action Indicated (OAI)3008420443
Jun 4, 2021Yonkers, NYDrugsOfficial Action Indicated (OAI)3008420443
Feb 23, 2018Yonkers, NYDrugsVoluntary Action Indicated (VAI)3008420443
Jan 11, 2017Yonkers, NYDrugsOfficial Action Indicated (OAI)3008420443

FDA Data Dashboard classifications: NAI (no action indicated), VAI (voluntary action indicated), OAI (official action indicated).