PYROLA Advanced Joint Formula capsules recalled over undeclared diclofenac

Recall date

June 12, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

D-1330-2015

FDA classification

Class I

Brand / firm

GC Natural Nutrition, Inc.

Sold / distributed

Nationwide

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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