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
D-0666-2024
Product summary
- Firm
- Guru Inc.
- Event
- Event 94893
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0666-2024
Official wording
Reason: Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Code information: Batch # IN-032, Exp 11/30/2027
Distribution pattern: Retail: South Carolina, North Carolina, Ohio; Consumer level: Nationwide within USA
Derived failure modes
-
Unknown
Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.