FDA-Drug2015-08-26Class I

PYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrition Inc., Fullerton, CA 92833, UPC 7 11746 00075 8.

GC Natural Nutrition, Inc.
Hazard

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared diclofenac, a prescription non-steroidal anti-inflammatory drug, and chlorpheniramine, an over-the-counter antihistimine, making this an unapproved drug.

Sold states
Nationwide
Affected count
12,000-15,000 bottles (estimated)
Manufactured in
1401 S Brookhurst Rd Ste 102, Fullerton, CA, United States
Products
PYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrition Inc., Fullerton, CA 92833, UPC 7 11746 00075 8.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1330-2015

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