D-0666-2024 Class II Ongoing
FDA drug recall D-0666-2024 was initiated by Guru Inc. on June 26, 2024 and is designated Class II. Reason for recall: Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone. The recall status is ongoing.
Recall Details
- Product Type
- Drugs
- Report Date
- October 2, 2024
- Initiation Date
- June 26, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
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.
Distribution Pattern
Retail: South Carolina, North Carolina, Ohio; Consumer level: Nationwide within USA
Code Information
Batch # IN-032, Exp 11/30/2027