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NMPA Announcement on the Cancellation of Registration Certificates for Phenolphthalein Tablets and Phenolphthalein Buccal Tablets

CCFDIE| Updated: 2021-01-14

According to Article 83 of the Drug Administration Law of the People's Republic of China, NMPA organized a post-marketing evaluation of phenolphthalein tablets and phenolphthalein lozenges, with the conclusion that these tablets have serious adverse reactions, rendering that the risk of use exceeds the benefit. The NMPA therefore decided the immediate cessation of production, sales and use of the two drugs in China with their registration certificates (drug approval number) revoked forthright. The two drugs that have been released on the market shall be recalled by the manufacturers. The recalled products shall be destroyed on-site under the supervision of the drug regulatory departments directly governing the manufacturers.