FDA recall D-0610-2024

Homeocare Laboratories, Inc. · Class II · drug

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

Reason for recall

Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism

Distribution

Nationwide to 60 Physician offices

Key facts

Status
Terminated
Initiation date
2024-06-05
Report date
2024-07-24
Termination date
2024-11-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Yonkers, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0610-2024