PYROLA Advanced Joint Formula Recalled for Undeclared Prescription Drugs
GC Natural Nutrition is recalling PYROLA Advanced Joint Formula capsules because they contain undeclared prescription and over-the-counter drugs.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric. The presence of undeclared prescription drugs in a consumer product poses a significant health risk.
Plain-English summary
GC Natural Nutrition, Inc. is recalling PYROLA Advanced Joint Formula capsules, 60-count bottles. The product was found to contain undeclared diclofenac, a prescription non-steroidal anti-inflammatory drug, and chlorpheniramine, an over-the-counter antihistamine. Because of these undeclared ingredients, the product is considered an unapproved drug and was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The recall involves an estimated 12,000 to 15,000 bottles distributed nationwide. All lots of the product are affected. The product is manufactured by G & C Natural Nutrition Inc. in Fullerton, CA, and can be identified by UPC 7 11746 00075 8.
Consumers should stop using the product and return it to the place of purchase for a refund. Individuals who have taken the product should consult their healthcare provider, particularly if they are taking other medications or have medical conditions that could be affected by diclofenac or chlorpheniramine.
The recalled product
- Product
- PYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrition Inc., Fullerton, CA 92833, UPC 7 11746 00075 8.
- Manufacturer
- GC Natural Nutrition, Inc.
- Category
- Drug — Dietary Supplement
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Distributed nationwide across the United States.
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