Drug Recall Enforcement Report Class II voluntary initiated by Guru Inc., originally initiated on 06-26-2024 for 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 The product was recalled due to marketed without an approved nda/anda: fda analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.. The product was distributed nationwide and the recall is currently ongoing.
| Field Name |
Field Value |
| Event ID |
94893 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number |
D-0666-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification |
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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern |
Retail: South Carolina, North Carolina, Ohio; Consumer level: Nationwide within USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| 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. What is the Reason for Recall?
Information describing how the product is defective. |
| Product Quantity |
Product Quantity
The amount of product subject to recall. |
| Voluntary Mandated |
Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date |
10-02-2024 |
| Recall Initiation Date |
06-26-2024 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification |
Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type |
Drugs |
| Recalling Firm |
Guru Inc. |
| Code Info |
Batch # IN-032, Exp 11/30/2027 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Status |
Ongoing |
