Multi-event June 2024 FDA Recall Stellalife Vega Oral Care by Homeocare Laboratories, Inc.
This Multi-event Class II drug recall was voluntarily initiated by Homeocare Laboratories, Inc. on June 5, 2024 for the product Stellalife Vega Oral Care. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0610-2024
Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
06-05-2024
07-24-2024
31,110 x 16 fl. oz. bottle
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide to 60 Physician offices
11-13-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
STELLALIFE 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 69685-143-16
Batch or Lot Expiration Information
Lot# 2550, exp. date 02-28-2026
Affected Packages Involved in this Recall
Recall Number: D-0609-2024
Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
06-05-2024
07-24-2024
31,811 x 1 fl. oz. spray bottle
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide to 60 Physician offices
11-13-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
Batch or Lot Expiration Information
Lot# 2552, exp. date 02-28-2026
