Drug recall: Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufactured For: Acutens, Inc., Sheridan, WY NDC
Homeocare Laboratories, Inc. (Yonkers, NY) initiated this drug recall on 5 Jun 2023; FDA lists 11 product records under event 92453, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 59% of the 281 drug enforcement events initiated in 2023 carry the same class.
Status: Terminated, terminated 16 Sep 2024. Initiation: voluntary: firm initiated. Homeocare Laboratories, Inc. has 2 enforcement events on this register, with a median of 11 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Homeocare Laboratories, Inc., Yonkers, NY.
Reason for recall
"cGMP deviations"
Distribution
"Product was distributed USA nationwide."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0880-2023 | Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufactured For: Acutens, Inc., Sheridan, WY NDC 80551-201-02 | 921 bottles | Class II | Terminated | 5 Jul 2023 |
| D-0881-2023 | Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New York, NY 10021 UPC 8 60208 00181 6 | 2,376 bottles | Class II | Terminated | 5 Jul 2023 |
| D-0882-2023 | Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distributed by Pharmadel LLC Georgetown, DE NDC 55758-036-01 | 5,956 bottles | Class II | Terminated | 5 Jul 2023 |
| D-0883-2023 | Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-035-01 | 5957 bottles | Class II | Terminated | 5 Jul 2023 |
| D-0884-2023 | DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15 | 12,850 tottles | Class II | Terminated | 5 Jul 2023 |
| D-0885-2023 | SnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99 | 200 liters/55 gallon drum | Class II | Terminated | 5 Jul 2023 |
| D-0886-2023 | StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-103-16 | 130,762/16 oz. tottles | Class II | Terminated | 5 Jul 2023 |
| D-0887-2023 | StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distributed by: StellaLife, Aventura, FL NDC 69685-113-16 | 16,587 bottles | Class II | Terminated | 5 Jul 2023 |
| D-0888-2023 | StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-101-02 | 40,034/1 fl. oz tubes | Class II | Terminated | 5 Jul 2023 |
| D-0889-2023 | StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-102-02 | 38,105/1 fl. oz. tubes | Class II | Terminated | 5 Jul 2023 |
| D-0890-2023 | StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-112-01 | 33,109/1 fl. oz. tubes | Class II | Terminated | 5 Jul 2023 |
Context
Other enforcement events for Homeocare Laboratories, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 5 Jun 2024 | STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 22875 NE 191 Street, | Drug | Class I | 2 |
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "cGMP deviations"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Product was distributed USA nationwide."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Sep 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.