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Recall Observatory FDA recall evidence

Drug product

PYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrition Inc., Fullerton, CA 92833, UPC 7 11746 00075 8.

D-1330-2015

June 12, 2015

Class I

Product summary

Firm
GC Natural Nutrition, Inc.
Event
Event 71480
Status
Terminated
Classification
Class I
Quantity
12,000-15,000 bottles (estimated)
Official record key
drug-enforcement:D-1330-2015

Official wording

Reason: 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.

Code information: All lots

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.