Xiamen Kang Zhongyuan Biotechnology Co., Ltd. — Class II: Discount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anesthetic, 30-cou
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. has initiated a Class II recall of Discount Drug Mart Food Market Menthol Cough Drops (NDC 83698-102-30) following an FDA inspection of the manufacturing facility on August 15, 2025. The recall was prompted by FDA observations during the inspection that may impact product quality.
This affects Xiamen Kang Zhongyuan Biotechnology Co., Ltd., the distributor Drug Mart-Food Fair, and downstream retailers or entities managing the supply of these specific 30-count menthol cough drops. Quality and compliance officers overseeing OTC drug manufacturing and distribution are primarily impacted.
The source indicates that the recall was initiated at the FDA's recommendation following a physical facility inspection, rather than a reported adverse event or analytical failure. This suggest that the observations made during the August 2025 inspection were significant enough to warrant a removal of product from the market, possibly due to concerns regarding Good Manufacturing Practice (GMP) deviations or systemic quality control issues at the China-based facility.
QA and supply chain teams should verify if any inventory of the specified NDC is currently held and follow standard quarantine procedures. For firms sourcing from international CMOs, this highlights the necessity of reviewing recent FDA Establish Inspection Reports (EIR) and Form 483 observations of foreign partners to preemptively assess product quality risks.
Class II. Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.. Product: Discount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anesthetic, 30-count bag, Distributed By: Drug Mart-Food Fair, Medina, Ohio 44256, Made in China, NDC: 83698-102-30, UPC: 093351037085.. Firm: Xiamen Kang Zhongyuan Biotechnology Co., Ltd. (Xiamen N/A China). Status: Ongoing.
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