FDA recall D-1330-2015

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-06-12

Report date

2015-08-26

Termination date

2015-12-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fullerton, CA, United States

Primary source

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