Drug Enforcement D-0666-2024

Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.

Status

Ongoing

Classification

Class II

Report Date

October 2, 2024

Termination Date

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Product Information

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
Product quantity
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Reason for recall
Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Recall initiation reason
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Initial firm notification
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Distribution pattern
Retail: South Carolina, North Carolina, Ohio; Consumer level: Nationwide within USA

Location & Firm

Recalling firm
Guru Inc.
Address
4370 Lawrenceville Hwy NW, # 2204

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0666-2024
Event ID
94893
Recall initiation date
June 26, 2024
Center classification date
September 23, 2024
Code info
Batch # IN-032, Exp 11/30/2027
More code info
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