Xiamen Kang Zhongyuan Biotechnology Co., Ltd. — Class II: exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor Cough Drop
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. has initiated a Class II recall for 'exchange select' Menthol Cough Suppressant Oral Anesthetic drops (Honey Lemon Flavor, 30-count) following an FDA inspection of the manufacturing facility. The agency recommended the recall based on observations made during an August 15, 2025, inspection that may impact product quality.
This affects Xiamen Kang Zhongyuan Biotechnology Co., Ltd., Medical Group Care, LLC, and entities distributing 'exchange select' brand OTC cough drops manufactured in China.
The recall acknowledges that observations made during an inspection can lead to a voluntary recall even if specific product defects have not been cited in the excerpt. This suggests the FDA identified systemic cGMP non-compliance or facility-level deficiencies significant enough to potentially compromise the quality of finished oral anesthetics. For regulatory professionals, this underscores the risk associated with adverse inspection findings at foreign manufacturing sites for OTC products.
Quality units should verify if materials or finished goods are sourced from this facility. Regulatory teams should ensure that foreign manufacturing sites are prepared for investigator observations regarding 'product quality' to prevent post-inspection recalls.
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: exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor Cough Drops, 30-count bag, Manufactured for Your Military Exchanges By: Medical Group Care, LLC., 1035 Collier Center Way, STE 5, Naples, FL, Made in China, NDC 83698-580-30, UPC: 614299398870.. Firm: Xiamen Kang Zhongyuan Biotechnology Co., Ltd. (Xiamen N/A China). Status: Ongoing.
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