Infla-650 Herbal Dietary Supplement, 700mg, packaged in pouches containing 60 capsules, Distributed by: Guru Inc., 4370
Summary
The FDA issued a Class II for Infla-650 Herbal Dietary Supplement, 700mg, packaged in pouches containing 60 c by Guru Inc.. Reason: Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone..
Details
Source
Drug Recall
External ID
D-0666-2024
Action Date
2024-10-02
Status
Ongoing
Category
drug
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
Lot/Code Info: Batch # IN-032, Exp 11/30/2027
Reason for Recall
Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Distribution
Retail: South Carolina, North Carolina, Ohio; Consumer level: Nationwide within USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-26
Company
Lilburn, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 31 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Guru Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Guru Inc. have FDA actions?
This is the only FDA action we have on record for Guru Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0666-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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