Xiamen Kang Zhongyuan Biotechnology Co., Ltd. — Class II: MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free, Honey Le
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. has initiated a Class II recall for MGC Health sugar-free honey lemon menthol cough drops (NDC 83698-125-25) following an FDA inspection of the manufacturing facility. The action was prompted by FDA observations during an August 15, 2025, inspection that signaled potential concerns regarding product quality.
This recall affects Xiamen Kang Zhongyuan Biotechnology Co., Ltd., the distributor Medical Group Care, LLC, and quality/compliance teams overseeing over-the-counter cough and cold oral anesthetics.
The FDA's recommendation for a recall based on facility inspection observations suggests that specific manufacturing site deficiencies were significant enough to potentially compromise the quality of finished drug products. This indicates a likely breakdown in current Good Manufacturing Practice (cGMP) standards, though the source does not detail the specific nature of the observations. Regulatory professionals should note the ongoing status of the recall and the timeline between the 2025 inspection and the 2026 recall classification.
Quality units should verify if any current inventory is sourced from Xiamen Kang Zhongyuan Biotechnology and evaluate the impact of the August 2025 inspection observations on product specifications. Regulatory teams should ensure NDC 83698-125-25 is removed from active distribution channels.
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: MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon, 25-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-125-25, UPC: 383173000085. Firm: Xiamen Kang Zhongyuan Biotechnology Co., Ltd. (Xiamen N/A China). Status: Ongoing.
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