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.
Product description
PYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrition Inc., Fullerton, CA 92833, UPC 7 11746 00075 8.
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1330-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jun 12, 2015
- FDA report date
- Aug 26, 2015
- Quantity
- 12,000-15,000 bottles (estimated)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GC Natural Nutrition, Inc.
Original FDA data
Every field from FDA enforcement report D-1330-2015, exactly as published.
Show all FDA fields
- City
- Fullerton
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 71480
- Address
- 1401 S Brookhurst Rd Ste 102
- Code information
- All lots
- Postal code
- 92833-4492
- Report date
- Aug 26, 2015
- Product type
- Drugs
- Recall number
- D-1330-2015
- Classification
- Class I
- Recalling firm
- GC Natural Nutrition, Inc.
- Product quantity
- 12,000-15,000 bottles (estimated)
- Termination date
- Dec 24, 2015
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrition Inc., Fullerton, CA 92833, UPC 7 11746 00075 8.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 12, 2015
- Initial firm notification
- Telephone
- Center classification date
- Aug 14, 2015