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.
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.
Consumers and healthcare providers should stop using this product immediately. Contact Xiamen Kang Zhongyuan Biotechnology Co., Ltd. or your healthcare provider for guidance. Notification method: Letter
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MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 80-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-80, UPC: 383173000030.. Generic: COUGH DROPS HONEY; Brand: MGC HEALTH. 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.. Classification: Class II. Quantity: N/A. Distribution: US Nationwide.
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Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Lack of Assurance of Sterility
Labeling: Missing Label
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.