Multi-event June 2023 FDA Recall Stellalife Vega Oral Care Rinse by Homeocare Laboratories, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Homeocare Laboratories, Inc. on June 5, 2023 for the product Stellalife Vega Oral Care Rinse. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0888-2023 TERMINATED D-0881-2023 TERMINATED D-0883-2023 TERMINATED D-0889-2023 TERMINATED D-0882-2023 TERMINATED D-0884-2023 TERMINATED D-0880-2023 TERMINATED D-0885-2023 TERMINATED D-0886-2023 TERMINATED D-0887-2023 TERMINATED D-0890-2023 TERMINATED

Recall Number: D-0888-2023

Reason for Recall
cGMP deviations
Initiated
06-05-2023
Reported
07-05-2023
Quantity
40,034/1 fl. oz tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92453
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Homeocare Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-16-2024
Product Description About Product Description
Full technical description of the product.
StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-101-02

Batch or Lot Expiration Information

Lot# 2335, exp. date Sep-23; 2364, exp. date Nov-23; 2408, exp. date Feb-24

Recall Number: D-0881-2023

Reason for Recall
cGMP deviations
Initiated
06-05-2023
Reported
07-05-2023
Quantity
2,376 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92453
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Homeocare Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-16-2024
Product Description About Product Description
Full technical description of the product.
Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New York, NY 10021 UPC 8 60208 00181 6

Batch or Lot Expiration Information

Lot# 2446, exp. Mar-24

Recall Number: D-0883-2023

Reason for Recall
cGMP deviations
Initiated
06-05-2023
Reported
07-05-2023
Quantity
5957 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92453
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Homeocare Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-16-2024
Product Description About Product Description
Full technical description of the product.
Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-035-01

Batch or Lot Expiration Information

Lot# 2413, exp. date Sep-24

Recall Number: D-0889-2023

Reason for Recall
cGMP deviations
Initiated
06-05-2023
Reported
07-05-2023
Quantity
38,105/1 fl. oz. tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92453
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Homeocare Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-16-2024
Product Description About Product Description
Full technical description of the product.
StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-102-02

Batch or Lot Expiration Information

Lot# 2334, exp. date Sep-23; 2363, exp. date Nov-23; 2365, exp. date Jan-24

Recall Number: D-0882-2023

Reason for Recall
cGMP deviations
Initiated
06-05-2023
Reported
07-05-2023
Quantity
5,956 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92453
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Homeocare Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-16-2024
Product Description About Product Description
Full technical description of the product.
Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distributed by Pharmadel LLC Georgetown, DE NDC 55758-036-01

Batch or Lot Expiration Information

Lot# 2414, exp. date Sep-24

Recall Number: D-0884-2023

Reason for Recall
cGMP deviations
Initiated
06-05-2023
Reported
07-05-2023
Quantity
12,850 tottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92453
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Homeocare Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-16-2024
Product Description About Product Description
Full technical description of the product.
DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15

Batch or Lot Expiration Information

Lot# 2423, exp. date Nov-24; 2445, exp. date Apr-25

Recall Number: D-0880-2023

Reason for Recall
cGMP deviations
Initiated
06-05-2023
Reported
07-05-2023
Quantity
921 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92453
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Homeocare Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-16-2024
Product Description About Product Description
Full technical description of the product.
Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufactured For: Acutens, Inc., Sheridan, WY NDC 80551-201-02

Batch or Lot Expiration Information

Lot# 2446, exp. date Mar-24

Recall Number: D-0885-2023

Reason for Recall
cGMP deviations
Initiated
06-05-2023
Reported
07-05-2023
Quantity
200 liters/55 gallon drum

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92453
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Homeocare Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-16-2024
Product Description About Product Description
Full technical description of the product.
SnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99

Batch or Lot Expiration Information

Lot# 2436, exp. date: unknown

Recall Number: D-0886-2023

Reason for Recall
cGMP deviations
Initiated
06-05-2023
Reported
07-05-2023
Quantity
130,762/16 oz. tottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92453
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Homeocare Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-16-2024
Product Description About Product Description
Full technical description of the product.
StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-103-16

Batch or Lot Expiration Information

Lot# 2357B,2333, exp. date Sep-2; 2367C, 2367D, exp. date Nov-23; 2367E, 2367F, exp. date Jan-24; 2395A, 2406, exp. date Feb-2; 2395B, exp. date Mar-24; 2395C, exp. date Apr-24

Affected Packages Involved in this Recall

69685-103-16 Stellalife Vega Oral Care Rinse

Recall Number: D-0887-2023

Reason for Recall
cGMP deviations
Initiated
06-05-2023
Reported
07-05-2023
Quantity
16,587 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92453
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Homeocare Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-16-2024
Product Description About Product Description
Full technical description of the product.
StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distributed by: StellaLife, Aventura, FL NDC 69685-113-16

Batch or Lot Expiration Information

Lot# 2396, exp. date Apr-24

Affected Packages Involved in this Recall

69685-113-16 Stellalife Vega Oral Care Coconut

Recall Number: D-0890-2023

Reason for Recall
cGMP deviations
Initiated
06-05-2023
Reported
07-05-2023
Quantity
33,109/1 fl. oz. tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92453
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Homeocare Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-16-2024
Product Description About Product Description
Full technical description of the product.
StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-112-01

Batch or Lot Expiration Information

Lot# 2407, exp. date Feb-24; 2409A, exp. date Apr-24; 2409B, exp. date May-24

Affected Packages Involved in this Recall

69685-112-01 Stellalife Vega Oral Care Gel
69685-115-01 Stellalife Vega Oral Care Recovery
69685-111-01 Stellalife Vega Oral Care