Guru Inc.: Drug Recall
Recall #D-0666-2024 · 06/26/2024
Class II: Risk
Recall Details
- Recall Number
- D-0666-2024
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Guru Inc.
- Status
- Ongoing
- Date Initiated
- 06/26/2024
- Location
- Lilburn, GA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
Reason for Recall
Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
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
Distribution Pattern
Retail: South Carolina, North Carolina, Ohio; Consumer level: Nationwide within USA
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.