FDA Recall D-1330-2015
GC Natural Nutrition, Inc. · Fullerton, CA
Class I — life-threatening Terminated 195 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-1330-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- Nationwide
- Recall initiated
- 2015-06-12
- Classified by FDA Center
- 2015-08-14
- FDA published
- 2015-08-26
- Terminated
- 2015-12-24
- Recalling firm
- GC Natural Nutrition, Inc.
- Firm location
- Fullerton, CA