June 2024 FDA Recall Drug by Guru Inc.
D-0666-2024 - Marketed without an approved NDA/ANDA

This Class II drug recall was voluntarily initiated by Guru Inc. on June 26, 2024 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0666-2024

Reason for Recall
Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Initiated
06-26-2024
Reported
10-02-2024
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94893
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Guru Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Retail: South Carolina, North Carolina, Ohio; Consumer level: Nationwide within USA
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Batch# IN-032, Exp 11/30/2027