Xiamen Kang Zhongyuan Biotechnology Co., Ltd. — Class II: MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 30-coun
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. initiated a Class II recall for MGC Health Menthol Cough Drops following an FDA recommendation linked to manufacturing facility inspection observations. The recall involves 30-count bags distributed by Medical Group Care, LLC.
This affects Quality Assurance and Compliance personnel at the manufacturing firm and the U.S. distributor, as well as regulatory professionals responsible for over-the-counter cough suppressant products.
The recall was triggered by facility-level observations during a 2025 inspection rather than a reported product failure, suggesting that identified CGMP deficiencies were significant enough to cast doubt on the quality or integrity of specific lots. This underscores the risk to distributors when manufacturing partners fail to maintain acceptable facility standards during FDA inspections.
Quality units should evaluate the oversight of foreign contract manufacturing partners, specifically ensuring that inspectional findings at the facility level are reconciled against released product batches. Regulatory teams should confirm that all distributed OTC cough suppression products from this manufacturer meet established quality specifications.
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, Honey Lemon, 30-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-30, UPC: 383173000047.. Firm: Xiamen Kang Zhongyuan Biotechnology Co., Ltd. (Xiamen N/A China). Status: Ongoing.
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