FDA recall D-0666-2024

Guru Inc. · Class II · drug

Product

Infla-650 Herbal Dietary Supplement, 700mg, packaged in pouches containing 60 capsules, Distributed by: Guru Inc., 4370 Lawrenceville Hwy NW, P.O. Box 2204, Lilburn, GA 30047-1100, USA. Ph.: 872 216 1566, http://www.dalayurevda.com, Made in India, UPC: 042535355019

Reason for recall

Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.

Distribution

Retail: South Carolina, North Carolina, Ohio; Consumer level: Nationwide within USA

Key facts

Status
Ongoing
Initiation date
2024-06-26
Report date
2024-10-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lilburn, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0666-2024