D-1330-2015 Class I Terminated
FDA drug recall D-1330-2015 was initiated by GC Natural Nutrition, Inc. on June 12, 2015 and is designated Class I. 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,… The recall status is terminated (terminated December 24, 2015). Affected quantity: 12,000-15,000 bottles (estimated).
Recall Details
- Product Type
- Drugs
- Report Date
- August 26, 2015
- Initiation Date
- June 12, 2015
- Termination Date
- December 24, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,000-15,000 bottles (estimated)
Product Description
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 Pattern
Nationwide
Code Information
All lots