Why it was recalled
Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
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 numbers, UPCs & expiration codes
Batch # IN-032, Exp 11/30/2027
Where it was sold
Retail: South Carolina, North Carolina, Ohio; Consumer level: Nationwide within USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0666-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 26, 2024
- FDA report date
- Oct 2, 2024
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Guru Inc.
Original FDA data
Every field from FDA enforcement report D-0666-2024, exactly as published.
Show all FDA fields
- City
- Lilburn
- State
- GA
- Status
- Ongoing
- Country
- United States
- Event ID
- 94893
- Address
- 4370 Lawrenceville Hwy NW
- Address (line 2)
- # 2204
- Code information
- Batch # IN-032, Exp 11/30/2027
- Postal code
- 30047-1100
- Report date
- Oct 2, 2024
- Product type
- Drugs
- Recall number
- D-0666-2024
- Classification
- Class II
- Recalling firm
- Guru Inc.
- Reason for recall
- Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Retail: South Carolina, North Carolina, Ohio; Consumer level: Nationwide within USA
- Recall initiation date
- Jun 26, 2024
- Center classification date
- Sep 23, 2024