PYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrition Inc., Fullerton, CA 92833, UPC 7 11746 00075 8.
FDA recall notice · announced August 26, 2015 · Gc Natural Nutrition
Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.
The product
PYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrition Inc., Fullerton, CA 92833, UPC 7 11746 00075 8.
Reason for recall
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.
Notes
Distribution: Nationwide
Lot/code information: All lots
Quantity: 12,000-15,000 bottles (estimated)
Status: Terminated
Products in this recall event:
- PYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrition Inc., Fullerton, CA 92833, UPC 7 11746 00075 8. (D-1330-2015)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.