Announcement of the State Food and Drug Administration on the cancellation of registration certificates for phenolphthalein tablets and phenolphthalein buccal tablets (No. 6 of 2021)

According to Article 83 of the "Drug Administration Law of the People's Republic of China", the State Drug Administration organized a post-marketing evaluation of phenolphthalein tablets and phenolphthalein lozenges.
The evaluation found that phenolphthalein tablets and phenolphthalein lozenges had serious adverse reactions.
The risk of use outweighs the benefit, and it is decided to stop the production, sales and use of phenolphthalein tablets and phenolphthalein lozenges in China from now on, and cancel the drug registration certificate (drug approval number)
.
The phenolphthalein tablets and phenolphthalein lozenges that have been on the market are recalled by the manufacturer, and the recalled products are supervised and destroyed by the drug regulatory authority where the company is located

Hereby announce

Attachment: List of manufacturers of phenolphthalein tablets and phenolphthalein lozenges

State Food and Drug Administration

January 8, 2021

Annex to Announcement No.