Buy-Herbal — Class I: Kian Pee Wan Capsules, 30-count bottles
Buy-Herbal has initiated an ongoing Class I recall for Kian Pee Wan Capsules (30-count bottles) due to the presence of undeclared drug ingredients, dexamethasone and cyproheptadine. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The recall affects Buy-Herbal, distributors of these capsules, and quality/compliance departments responsible for screening herbal products for synthetic drug adulterants.
A Class I designation indicates the FDA's assessment of a high risk for serious adverse health consequences or death. The presence of a corticosteroid (dexamethasone) and an antihistamine (cyproheptadine) in a product marketed without drug approval suggests a significant failure in raw material controls and regulatory oversight. This may indicate increased agency scrutiny on the herbal supplement supply chain for undeclared pharmaceutical actives.
Verify that all incoming herbal or dietary supplement products are screened for pharmaceutical adulterants. Review supplier qualification programs to ensure third-party manufacturers are not incorporating active pharmaceutical ingredients into products marketed as supplements. Immediate quarantine of the affected 30-count bottles is necessary.
Class I. Reason: Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.. Product: Kian Pee Wan Capsules, 30-count bottles. Firm: Buy-Herbal (Flushing NY United States). Status: Ongoing.
Open in openFDA / FDA.gov