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
- Company
- Guru Inc.
- Recall Initiated
- June 26, 2024
- Posted
- October 2, 2024
- Recall Number
- D-0666-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Lilburn, GA, United States
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
Lot / Code Info
Batch # IN-032, Exp 11/30/2027
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