China NMPA Product Recall - Dorex Sodium Fluoride Dental Care (for oral use)

Colgate-Palmolive (China) Co., Ltd., in coordination with Colgate-Palmolive (UK) Limited, initiated a voluntary Class III recall of its Dorex Sodium Fluoride Dental Care Products (Dental Use) in China. The recall, reported to the National Medical Products Administration (NMPA) on December 4, 2017, affects three specific batches: 191284, 193327, and 193328, totaling 9,925 units. The primary issue identified, through sample inspection and dentist feedback, was the potential for uneven product composition due to phase separation of ingredients. This condition, caused by prolonged exposure to high temperatures, could lead to an inconsistent distribution of fluoride, impacting the product's efficacy for preventing caries and decalcification. As required by the NMPA, the company's corrective actions include replacing all affected products with new stock from distributors, dentists, and hospitals. Recalled products will be centrally scrapped according to regulatory and company protocols. Furthermore, Colgate-Palmolive has implemented stringent temperature controls for the storage and transportation of new products, with clear temperature guidelines to be included on the product packaging, to prevent recurrence of this temperature-related quality issue. This action ensures adherence to quality standards under the national medical device regulatory framework.