PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: October 2, 2024 Initiated: June 26, 2024 #D-0666-2024

Product Description

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.

Details

Recalling Firm
Guru Inc.
Distribution
Retail: South Carolina, North Carolina, Ohio; Consumer level: Nationwide within USA
Location
Lilburn, GA

Frequently Asked Questions

What product was recalled?
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. Recalled by Guru Inc..
Why was this product recalled?
Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 2, 2024. Severity: Moderate. Recall number: D-0666-2024.